依折麦布药物报告 ezetimibe drug report - yaozh.com€¦ · torrent pharma gmbh südwestpark...
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2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 1/71
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依折麦布药物报告ezetimibe Drug Report
药物英文名 ezetimibe
药物中文名 依折麦布
药物别名 Zetia; SCH58235
原研单位 Essex (Originator), Schering-Plough (Originator), Merck & Co. (Licensee)
全球最高状态 2002年批准上市
中国是否上市 是
依折麦布（Ezetimibe）由默沙东（MSD）研发，于2002年10月25日获美国食品药品管理局（FDA）批准，之后于2007年4月18日获日本医药品医疗器械综合机构（PMDA）批准，由默沙东上市销售，商品名为Zetia。依折麦布是一种胆固醇吸收抑制剂。它抑制了小肠中胆固醇的吸收，降低肝脏细胞里胆固醇的含量，促使循环中胆固醇的吸收增加，从而降低了血液中胆固醇含量。主要用于辅助饮食治疗原发性高脂血症，混合型高脂血症，纯合子家族性高胆固醇血症和纯合子谷甾醇血症（植物固醇血症）。Zetia为口服片剂，每片含10 mg 依折麦布。推荐剂量为每日1次，每次10 mg，随餐或空腹均可。
结构式
化学名称：(3R,4S)-1-(p-fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone
CAS登记号：163222-33-1
分子式：C24H21F2NO3
分子量：409.4299
ATC分类
摘要信息
药物概述
API信息
药理作用
2017/11/21 ezetimibe Drug Report
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C10AX09 心血管系统 > 血脂调节剂 > 血脂调节剂，单方 > 其它血脂调节剂
作用靶点
Niemann-Pick C1-like protein-1 inhibitor
申请号 商标名 活性成分 剂型/给药途径 批准时间 申请机构
021445 ZETIA EZETIMIBE TABLET;ORAL 2002-10-25 MSD INTL GMBH
201790 EZETIMIBE EZETIMIBE TABLET; ORAL 2013-08-07 MYLAN PHARMS INC
078560 EZETIMIBE EZETIMIBE TABLET;ORAL 2015-06-26 GLENMARK PHARMS LTD
208803 EZETIMIBE EZETIMIBE TABLET;ORAL 2017-06-12 AMNEAL PHARMS CO
208332 EZETIMIBE EZETIMIBE TABLET;ORAL 2017-06-12 APOTEX INC
200831 EZETIMIBE EZETIMIBE TABLET;ORAL 2017-06-12 WATSON LABS INC
207311 EZETIMIBE EZETIMIBE TABLET;ORAL 2017-06-12 OHM LABS INC
078724 EZETIMIBE EZETIMIBE TABLET;ORAL 2017-06-12 TEVA PHARMS USA
204331 EZETIMIBE EZETIMIBE TABLET;ORAL 2017-06-12 ZYDUS PHARMS USA INC
203931 EZETIMIBE EZETIMIBE TABLET;ORAL 2017-06-12 SANDOZ INC
209838 EZETIMIBE EZETIMIBE TABLET;ORAL 2017-08-25
编号 药品名称 活性成分 剂型 上市许可持有人 获批时间
DE/H/0396
/
EZETROL 10mg Tabletten
ezetimibe 10
mg
Tablet
Merck Sharp & Dohme Ltd. Hertford Road GB-EN119BU Hoddesdon, Hertfordshire United Kingdom
2003-03-04
DE/H/0399
/
EZETIMIBEMSD-SP 10
mg Tabletten
ezetimibe 10
mg
Tablet
Merck Sharp & Dohme Ltd. Hertford Road GB-EN119BU Hoddesdon, Hertfordshire United Kingdom
2003-03-04
DE/H/0397
/
ZIENT 10 mgTabletten
ezetimibe 10
mg
Tablet
Merck Sharp & Dohme Ltd. Hertford Road GB-EN119BU Hoddesdon, Hertfordshire United Kingdom
2003-03-04
DE/H/0398
/
VIEMM 10 mgTabletten
ezetimibe 10
mg
Tablet
Merck Sharp & Dohme Ltd. Hertford Road GB-EN119BU Hoddesdon, Hertfordshire United Kingdom
2003-03-04
美国上市情况(11条)
欧盟上市情况(51条) 隐藏
2017/11/21 ezetimibe Drug Report
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编号 药品名称 活性成分 剂型 上市许可持有人 获批时间
SI/H/0105
/
Ezoleta 10 mgtablets
ezetimibe 10
mg
Tablet
Krka, d.d., Novo mesto, Slovenia 2009-10-08
HU/H/0217
/
Ezetimibe-Teva
ezetimibe 10
mg
Tablet
TEVA Magyarország Zrt Rákóczi út 70-72, Budapest,H-1074 Hungary
2010-01-07
DK/H/1759
/
Coltowanezetimibe 10
mg
Tablet
Gedeon Richter Plc. 1103 Budapest Gyömroi út 19-21Hungary
2010-09-16
HU/H/0318
/
Lipobonezetimibe 10
mg
Tablet
EGIS Pharmaceuticals Plc. H-1106 Budapest,Keresztúri út 30-38. [email protected]
2012-02-29
AT/H/0441
/
EzetimibSandoz 10 mg
- Tabletten
ezetimibe 10
mg
Tablet
Sandoz GmbH Biochemiestrasse 10 6250 Kundl 2013-02-15
AT/H/0442
/
EzetimibHexal 10 mg -
Tabletten
ezetimibe 10
mg
Tablet
Hexal Pharma GmbH Stella-Klein-Löw Weg 17 1020Wien
2013-02-15
CZ/H/0219
/
Ezen 10 mgezetimibe 10
mg
Tablet
Zentiva, k.s., U kabelovny 130 102 37 Praha 10 -Dolní MÄ›cholupy The Czech Republic
2013-03-13
DE/H/3732
/
EZETIMIBBASICS 10 mg
Tabletten
ezetimibe 10
mg
Tablet
Basics GmbH Hemmelrather Weg 201 51377Leverkusen Germany
2014-01-23
NL/H/2923
/
EzetimibeMylan 10 mg
ezetimibe 10
mg
Tablet
Mylan B.V. Dieselweg 25 3752 LB Bunschoten TheNetherlands
2014-05-20
DK/H/2317
/
EzetimibRichter
ezetimibe 10
mg
Tablet
Gedeon Richter Plc. GyömrÅ‘i út 19-21 Budapest1103 Hungary
2014-06-11
NL/H/3139
/
EzetimibeGlenmark 10mg Tabletten
ezetimibe 10
mg
Tablet
Glenmark Pharmaceuticals Europe Limited LaxmiHouse, 2B Draycott Avenue, Kenton, Harrow,
Middlesex HA3 0BU United Kingdom2015-05-08
NL/H/3191
/
EzetimibeUriach 10 mg
tablets
ezetimibe 10
mg
Tablet
J.Uriach y Compañía, S.A. Av. Camí Reial, 51-5708184 Palau-Solità i Plegamans (Barcelone) Spain
2015-05-26
2017/11/21 ezetimibe Drug Report
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编号 药品名称 活性成分 剂型 上市许可持有人 获批时间
DK/H/2467
/
Carditimibezetimibe 10
mg
Tablet
Gedeon Richter Plc. GyömrÅ‘i út 19-21 1103Budapest Hungary
2015-11-18
DK/H/2444
/
Intestatezetimibe 10
mg
Tablet
Gedeon Richter Plc. GyömrÅ‘i út 19-21 1103Budapest Hungary
2015-11-18
ES/H/0329
/
EzetimibaAccord 10mg
tablets
ezetimibe 10
mg
Tablet
Accord Healthcare Limited Sage house, 319 Pinnerroad, North Harrow, Middlesex, HA1 4HF, United
Kingdom2016-03-08
ES/H/0330
/
Ezetimibaastron
ezetimibe 10
mg
Tablet
Astron Research Ltd. Accord Healthcare Limited Sagehouse, 319 Pinner road, North Harrow, Middlesex,
HA1 4HF, United Kingdom2016-03-08
DE/H/4286
/
Ezetimib-ratiopharm
ezetimibe 10
mg
Tablet
Teva Nederland B.V. Swensweg 5 NL-2031 GAHAARLEM
2016-04-18
DE/H/4285
/
Ezetimib AbZ10 mg
ezetimibe 10
mg
Teva Nederland B.V. Swensweg 5 NL-2031 GAHAARLEM
2016-04-18
NL/H/3516
/
Ezetimib CFezetimibe 10
mg
Tablet
STADA Arzneimittel AG Stadastrasse 2-18 61118 BadVilbel Germany
2016-07-27
NL/H/3731
/
EzetimibeSTADA 10 mg,
tabletten
ezetimibe 10
mg
Tablet
Stada Arzneimittel AG Stadast. 2-18 Bad Vilbel 61118Germany
2016-07-27
ES/H/0385
/
EzetimibeAlter 10 mg
tablets
ezetimibe 10
mg
Tablet
LABORATORIOS ALTER, S.A. C/ Mateo Inurria, 3028036, Madrid Spain
2016-08-10
PT/H/1569
/
EzetimibaMiril
ezetimibe 10
mg
Tablet
ToLife - Produtos Farmacêuticos, S.A. 2016-10-12
SI/H/0163
/
EzetimibeKrka 10 mg
tablets
ezetimibe 10
mg
Tablet
Krka, d.d., Novo mesto Šmarješka cesta 6 8501Novo mesto Slovenia
2016-10-18
SI/H/0168
/
EzetimibeKrka 10 mg
tablets
ezetimibe 10
mg
Tablet
Krka, d.d., Novo mesto Šmarješka cesta 6 8501Novo mesto Slovenia
2016-10-18
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编号 药品名称 活性成分 剂型 上市许可持有人 获批时间
SI/H/0170
/
Ylerse 10 mgtablets
ezetimibe 10
mg
Tablet
Krka, d.d., Novo mesto Šmarješka cesta 6 8501Novo mesto Slovenia
2016-10-18
DE/H/4417
/
EzetimibHeumann 10mg Tabletten
ezetimibe 10
mg
Tablet
Torrent Pharma GmbH Südwestpark 50 D-90449Nürnberg
2016-10-19
NL/H/3473
/
EzetimibeApotex 10mg, tablets
ezetimibe 10
mg
Tablet
Apotex Europe B.V. Darwinweg 20 2333 CR LeidenNetherlands
2016-10-26
NL/H/3620
/
EzetimibeApotex 10mg, tablets
ezetimibe 10
mg
Tablet
Apotex Europe B.V. Darwinweg 20 2333 CR LeidenNetherlands
2016-10-26
DK/H/2563
/
EzetimibeActavis
ezetimibe 10
mg
Tablet
Actavis Group PTC ehf., Reykjavíkurvegi 76-78 220Hafnarfjörður Iceland
2016-12-20
DK/H/2564
/
Colezenezetimibe 10
mg
Tablet
SF Group 2016-12-20
DK/H/2565
/
Mibecolezetimibe 10
mg
Tablet
SF Group 2016-12-20
DK/H/2572
/
EzetimibeDOC Generici
ezetimibe 10
mg
Tablet
DOC Generici Srl Via Turati 40, Milano 20121 Italia 2016-12-20
DK/H/2573
/
EzetimibeAlchemia
ezetimibe 10
mg
Tablet
Alchemia Ltd 2016-12-20
DK/H/2574
/
Alchetmibelezetimibe 10
mg
Tablet
Alchemia Limited, 5th Floor, 86 Jermyn Street,London SW1Y 6AW United Kingdom
2016-12-20
DK/H/2630
/
EzetimibSigillata
ezetimibe 10
mg
Tablet
Sigillata Limited Suite 23, Park Royal House 23 ParkRoyal Rd United Kingdom NW10 7JH London United
Kingdom2016-12-20
DK/H/2661
/
Zertyaezetimibe 10
mg
Tablet
Pharmahten S.A. 6 Deveniakon Str 153 51 PalliniAttiki Greece
2016-12-20
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编号 药品名称 活性成分 剂型 上市许可持有人 获批时间
NL/H/3693
/
Ezegal 10 mgomhuldetabletten
ezetimibe 10
mg
Coatedtablet
Laboratoires SMB SA 26-28, rue de la Pastorale B-1080 Bruxelles
2017-02-08
UK/H/6322
/
Ezetimibe10mg tablets
ezetimibe 10
mg
Tablet
LUPIN (EUROPE) LIMITED VICTORIA COURT BEXTONROAD KNUTSFORD WA16 0PF UNITED KINGDOM
2017-05-04
PL/H/0431
/
EzetimibeAdamed
ezetimibe 10
mg
Tablet
Adamed Sp. z o.o. Pienkow 149 05-152 CzosnowPoland
2017-05-09
PL/H/0445
/
Ezetimibe+pharma
ezetimibe 10
mg
Tablet
+pharma arzneimittel gmbh Hafnerstrasse 211 Graz8054 Austria
2017-05-09
PT/H/1655
/
EztimibeRafarm
ezetimibe 10
mg
Tablet
Rafarm, S.A. 2017-05-17
FI/H/0915
/
EzetimibAmneal
ezetimibe 10
mg
Tablet
Amneal Pharma Europe Limited 70 Sir JohnRogerson's Quay Dublin 2 Ireland
2017-05-22
FI/H/0916
/
Ezeliconezetimibe 10
mg
Tablet
Laboratorios Liconsa S.A. Gran Via Carlos III, 98, 7thfloor 08028 Barcelona Spain
2017-05-22
FI/H/0917
/
EzetimibLiconsa
ezetimibe 10
mg
Tablet
Laboratorios Liconsa S.A. Gran Via Carlos III, 98, 7thfloor 08028 Barcelona Spain
2017-05-22
PT/H/1684
/
EztimibeVenifar
ezetimibe 10
mg
Tablet
Venifar, Ltd. 2017-06-07
DK/H/2700
/
CILDARezetimibe 10
mg
Tablet
MEDOCHEMIE HELLAS SA 6, Pasteur street,Ampelokipi Athens Greece
2017-08-15
DE/H/5110
/
EzetimibMicro Labs 10mg Tabletten
ezetimibe 10
mg
Tablet
Micro Labs GmbH Lyoner Straβe 14 60528 FrankfurtGermany
2017-10-04
商标名 活性成份 申请类型 申请公司 批准日期
日本上市情况(3条)
2017/11/21 ezetimibe Drug Report
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Zetia Tablets 10mg
Ezetimibe
Approval
(Schering-plough K.K.)2007/04/1
8
ゼチーア錠10mgEzetimib
e製造販売元／ＭＳＤ株式会社 1986/03
ゼチーア錠10mgEzetimib
e製造販売元／ＭＳＤ株式会社 販売元／バイエル薬品株式
会社1992/08
国家名称 上市公司 商标名 活性成分 适应症 状态
Arg Phoenix Acotral Ezetimibe 高胆固醇血症
Arg Lazar Alin Ezetimibe 高胆固醇血症
Arg Bernabo Alipas Ezetimibe 高胆固醇血症
Arg Beta Cerclerol Ezetimibe 高胆固醇血症
Arg LKM Cetrakam Ezetimibe 高胆固醇血症
Arg Gador Coracil Ezetimibe 高胆固醇血症
India Unichem Ezetib Ezetimibe 高胆固醇血症
Arg. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Austral. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Austria Aesca Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Austria MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Belg. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Braz. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Canad. Merck Frosst Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Canad. Schering Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Chile MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Cz. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Denm. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Fin. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Fr. MSD-Chibret Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Ger. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Gr. Vianex (Βιανεξ) Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Hong Kong MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Hong Kong Schering-Plough Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Hung. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Indon. Schering-Plough Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Irl. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
主要上市国家/地区(63条) 隐藏
2017/11/21 ezetimibe Drug Report
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国家名称 上市公司 商标名 活性成分 适应症 状态
Israel MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Malaysia MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Malaysia Schering-Plough Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Mex. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
NZ MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Neth. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Norw. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Philipp. Schering-Plough Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Port. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Rus. Schering-Plough Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
S.Afr. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Singapore MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Singapore Schering-Plough Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Spain MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Swed. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Swed. Schering-Plough Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Switz. MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Thai. Schering- Plough Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
UK MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
Venez MSD Ezetrol Ezetimibe 动脉粥样硬化;高胆固醇血症
India* Glenmark Ezzicad Ezetimibe 高胆固醇血症 可能已退市
India Ipca Imbibe Ezetimibe Hyperlipidaemias
Arg Roemmers Ixacor Ezetimibe 高胆固醇血症
Arg Casasco Nalecol Ezetimibe 高胆固醇血症
Arg Klonal Sinterol Ezetimibe 高胆固醇血症
Arg Elea Trilip Ezetimibe 高胆固醇血症
Arg Ivax Vadel Ezetimibe Hyperlipidaemias
Arg. Schering-Plough Zetia Ezetimibe 高胆固醇血症
Braz. Mantecorp Zetia Ezetimibe 高胆固醇血症
USA Merck Zetia Ezetimibe 高胆固醇血症
USA Schering- Plough Zetia Ezetimibe 高胆固醇血症
Venez Schering-Plough Zetia Ezetimibe 高胆固醇血症
Chile Essex Zient Ezetimibe 动脉粥样硬化;高胆固醇血症;谷固醇血症
Cz. MSD Zient Ezetimibe 动脉粥样硬化;高胆固醇血症;谷固醇血症
2017/11/21 ezetimibe Drug Report
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国家名称 上市公司 商标名 活性成分 适应症 状态
Mex. Schering-Plough Zient Ezetimibe 动脉粥样硬化;高胆固醇血症;谷固醇血症
Venez Schering- Plough Zient Ezetimibe 动脉粥样硬化;高胆固醇血症;谷固醇血症
药品名称 批准文号 药品规格 生产厂商 国产厂家数量 是否医保
依折麦布片 H20160181 10mg MSD International GmbH (Singapore Branch) 新加坡进口
依折麦布片 H20171017 10mg MSD International GmbH (Singapore Branch) 新加坡进口
依折麦布片 J20171023 10mg MSD International GmbH (Singapore Branch) 新加坡进口
受理号码 药品名称 申请类型 注册分类 承办日期 企业名称 办理状态 状态开始日期 审批结论
J0300542依折麦布
片进口 3.1
2003-05-04
MSP 新加坡公司
已发批件 2003-11-27 批准临床
JXHS0500036
依折麦布片
进口 3.12005-04-
27MSP新
加坡公司制证结束待发
送-已批准2006-04-19 批准进口
JYHB0700587
依折麦布片
补充申请2007-05-
24
Schering-
PloughLaboN.V.
已发批件 2007-12-29 批准补充
JYHB0700629
依折麦布片
补充申请2007-05-
30
MSPSINGAP
ORECOMPANY LLC
制证完毕－已发批件
2008-04-14 批准补充
JYHB0901010
依折麦布片
补充申请2009-11-
25
MSPSingapo
reCompany,LLC
制证完毕－已发批件
2010-06-07 批准补充
JXHS1100053
依折麦布 进口2011-05-
11
TevaAPI
IndiaLimited
制证完毕－已发批件
2012-06-29终止审批
程序
JXHL1200201
依折麦布 进口2012-06-
29印思特实
验室制证完毕－已
发批件2016-05-24 批准临床
CXHS1200189
依折麦布 新药 3.12012-08-
22
江苏豪森医药集团连云港宏创医药有
限公司
制证完毕－已发批件
2014-01-07 批准临床
CYHS1200932
依折麦布片
仿制 62012-10-
23
江苏豪森药业股份有限公司
制证完毕－已发批件
2014-01-07 批准临床
中国上市情况(3条)
中国注册申报情况(91条) 隐藏
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 10/71
受理号码 药品名称 申请类型 注册分类 承办日期 企业名称 办理状态 状态开始日期 审批结论
JXHL1200391
依折麦布 进口2012-12-
17
TevaAPI
IndiaLimited
制证完毕－已发批件
2015-11-26 批准临床
CYHS1300095
依折麦布片
仿制 62013-04-
22
南京先声东元制药有限公司
制证完毕－已发批件
2015-12-24 批准临床
CXHS1300020
依折麦布 新药 3.12013-04-
22
南京先声东元制药有限公司
制证完毕－已发批件
2015-12-15 批准临床
CYHS1300171
依折麦布片
仿制 62013-06-
20
南京柯菲平盛辉制药有限公
司
制证完毕－已发批件
2015-11-25 批准临床
CXHS1300024
依折麦布 新药 3.12013-06-
21
四川制药制剂有限
公司
制证完毕－已发批件
2015-12-15 不批准
CXHS1300126
依折麦布 新药 3.12013-06-
28
重庆圣华曦药业股份有限公
司
制证完毕－已发批件
2015-12-24 批准临床
CYHS1300686
依折麦布片
仿制 62013-07-
11
重庆圣华曦药业股份有限公
司
制证完毕－已发批件
2015-12-24 批准临床
CYHS1300433
依折麦布片
仿制 62013-08-
02
深圳致君制药有限
公司
制证完毕－已发批件
2016-08-12 批准临床
CXHL1300647
依折麦布 新药 3.12013-08-
07
重庆华邦胜凯制药有限公司
制证完毕－已发批件
2016-01-14 批准临床
CYHS1301003
依折麦布片
仿制 62013-09-
02
重庆华邦制药有限
公司
制证完毕－已发批件
2016-01-14 批准临床
CYHS1301034
依折麦布片
仿制 62013-10-
15
四川制药制剂有限
公司
制证完毕－已发批件
2015-12-15 批准临床
CYHS1301216
依折麦布片
仿制 62013-12-
11
重庆福安药业集团庆余堂制药有限公
司
制证完毕－已发批件
2016-01-22 批准临床
CXHL1300822
依折麦布 新药 3.12013-12-
11
重庆福安药业（集团）股份有限公司
制证完毕－已发批件
2016-01-22 批准临床
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 11/71
受理号码 药品名称 申请类型 注册分类 承办日期 企业名称 办理状态 状态开始日期 审批结论
JYHB1301838
依折麦布片
补充申请2014-01-
24
MSPSingapo
reCompany, LLC
制证完毕－已发批件
2014-08-27
JXHL1400033
依折麦布 进口2014-02-
19
华科医药知识产权咨询中心
在审评审批中 2014-02-17
CYHS1302093
依折麦布片
仿制 62014-03-
19
武汉启瑞药业有限
公司
制证完毕－已发批件
2016-01-29 批准临床
CXHB1400031
依折麦布等32个
品种补充申请
2014-04-02
福安药业（集团）股份有限
公司
审批完毕 2014-08-20
CYHS1300491
依折麦布片
仿制 62014-04-
09
山东罗欣药业股份有限公司
制证完毕－已发批件
2016-01-28 批准临床
CXHS1300091
依折麦布 新药 3.12014-04-
09
山东罗欣药业股份有限公司
制证完毕－已发批件
2016-01-28 批准临床
CXHS1400010
依折麦布 新药 3.12014-04-
11
江西施美制药有限
公司
制证完毕－已发批件
2016-02-04 批准临床
CXHS1400068
依折麦布 新药 3.12014-04-
14
湖南有色凯铂生物药业有限
公司
制证完毕－已发批件
2016-03-01 批准临床
CXHS1300257
依折麦布 新药 3.12014-04-
21
常州制药厂有限公
司
制证完毕－已发批件
2016-01-28 批准临床
CYHS1301700
依折麦布片
仿制 62014-04-
28
浙江华海药业股份有限公司
制证完毕－已发批件
2016-02-19 批准临床
CXHS1400022
依折麦布 新药 3.12014-06-
06
湖南方盛制药股份有限公司
制证完毕－已发批件
2016-01-29 批准临床
CYHS1400074
依折麦布片
仿制 62014-06-
06
湖南方盛制药股份有限公司
制证完毕－已发批件
2016-01-29 批准临床
CYHS1400497
依折麦布片
仿制 62014-06-
18
扬子江药业集团广州海瑞药业有限公
司
制证完毕－已发批件
2016-01-28 批准临床
CXHS1300307
依折麦布 新药 3.12014-06-
23
浙江华海药业股份有限公司
制证完毕－已发批件
2016-02-19 批准临床
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 12/71
受理号码 药品名称 申请类型 注册分类 承办日期 企业名称 办理状态 状态开始日期 审批结论
JXHL1400118
依折麦布 进口2014-06-
23格兰马克有限公司
制证完毕－已发批件
2016-01-15 批准临床
CYHS1400333
依折麦布片
仿制 62014-07-
03
北京万生药业有限责任公司
制证完毕－已发批件
2016-01-28 批准临床
CYHS1400411
依折麦布片
仿制 62014-07-
24
海南皇隆制药股份有限公司
制证完毕－已发批件
2016-02-04 批准临床
CYHS1400214
依折麦布片
仿制 62014-07-
30
石药集团欧意药业有限公司
制证完毕－已发批件
2016-02-04 批准临床
JXHL1400268
依折麦布片
进口2014-08-
07吉瑞大药
厂制证完毕－已
发批件2016-10-18 批准临床
CYHS1400471
依折麦布片
仿制 62014-08-
11
海南锦瑞制药有限
公司
制证完毕－已发批件
2016-03-01 批准临床
CYHS1400037
依折麦布片
仿制 62014-08-
26
江西施美制药有限
公司
制证完毕－已发批件
2016-02-04 批准临床
CYHS1400460
依折麦布片
仿制 62014-09-
03北京协和
药厂制证完毕－已
发批件2016-02-19 批准临床
CYHS1301461
依折麦布片
仿制 62014-09-
09
常州制药厂有限公
司
制证完毕－已发批件
2016-02-03 批准临床
CXHL1401011
依折麦布 新药 3.12014-09-
11
湖北华世通生物医药科技有
限公司
制证完毕－已发批件
2016-02-19 批准临床
CYHS1401033
依折麦布片
仿制 62014-09-
28
湖北华世通潜龙药业有限公
司
制证完毕－已发批件
2016-02-04 批准临床
CYHS1400306
依折麦布片
仿制 62014-10-
16
华润赛科药业有限责任公司
制证完毕－已发批件
2016-02-19 批准临床
CXHS1400233
依折麦布 新药 3.12014-11-
02
连云港宏创药业有
限公司
制证完毕－已发批件
2016-12-30
CXHS1400209
依折麦布 新药 3.12014-11-
03
齐鲁天和惠世制药有限公司
制证完毕－已发批件
2016-02-29 批准临床
CYHS1490077
依折麦布片
仿制 62014-11-
03
江苏豪森药业股份有限公司
制证完毕－已发批件
2016-03-17 企业撤回
CXHL1401576
依折麦布 新药 3.12014-12-
19
廊坊高博京邦制药有限公司
制证完毕－已发批件
2016-05-12 批准临床
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 13/71
受理号码 药品名称 申请类型 注册分类 承办日期 企业名称 办理状态 状态开始日期 审批结论
CYHS1401374
依折麦布片
仿制 62015-01-
07
西安葛蓝新通制药有限公司
制证完毕－已发批件
2016-05-04 批准临床
CXHL1401498
依折麦布 新药 3.12015-01-
07
陕西大生制药科技有限公司
制证完毕－已发批件
2016-05-04 批准临床
CYHS1401409
依折麦布片
仿制 62015-01-
14
云南白药集团大理药业有限责任公司
制证完毕－已发批件
2016-02-18 批准临床
CXHL1401903
依折麦布 新药 3.12015-02-
26天方药业有限公司
制证完毕－已发批件
2016-03-01 批准临床
CXHL1402021
依折麦布 新药 3.12015-02-
26
武汉长联来福制药股份有限
公司
制证完毕－已发批件
2016-05-19 批准临床
CXHS1500010
依折麦布 新药 3.12015-03-
24
浙江天宇药业股份有限公司
制证完毕－已发批件
2016-05-12 批准临床
CYHS1401741
依折麦布片
仿制 62015-05-
15天方药业有限公司
制证完毕－已发批件
2016-03-01 批准临床
CXHL1500277
依折麦布 新药 3.12015-05-
25
江苏兰健药业有限
公司
制证完毕－已发批件
2016-05-19 批准临床
CXHL1500503
依折麦布 新药 3.12015-05-
25
常州亚邦制药有限
公司
制证完毕－已发批件
2016-05-19 批准临床
CXHL1500834
依折麦布 新药 3.12015-07-
08
山东铂源药业有限
公司
制证完毕－已发批件
2016-07-14 批准临床
CXHL1401828
依折麦布 新药 3.12015-08-
04
上海现代制药股份有限公司
制证完毕－已发批件
2016-06-27 批准临床
CXHL1501404
依折麦布 新药 3.12015-08-
20
武汉武药制药有限
公司
制证完毕－已发批件
2016-08-01 批准临床
CYHS1500444
依折麦布片
仿制 62015-09-
06
华润双鹤药业股份有限公司
制证完毕－已发批件
2016-05-12 批准临床
CYHS1500603
依折麦布片
仿制 62015-09-
16
苏州中化药品工业有限公司
制证完毕－已发批件
2016-05-19 批准临床
CXHL1501207
依折麦布 新药 3.12015-09-
18
山东新时代药业有
限公司
制证完毕－已发批件
2016-10-24 批准临床
CYHS1500492
依折麦布片
仿制 62015-09-
21
北京利龄恒泰药业有限公司
制证完毕－已发批件
2016-05-12 批准临床
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 14/71
受理号码 药品名称 申请类型 注册分类 承办日期 企业名称 办理状态 状态开始日期 审批结论
CXHL1500896
依折麦布 新药 3.12015-09-
21
成都恒瑞制药有限
公司
制证完毕－已发批件
2016-08-01 批准临床
CXHL1501541
依折麦布 新药 3.12015-09-
22
浙江普洛得邦制药有限公司
制证完毕－已发批件
2016-09-03 批准临床
CYHS1401677
依折麦布片
仿制 62015-09-
25
上海现代制药股份有限公司
制证完毕－已发批件
2016-06-27 批准临床
CYHS1500737
依折麦布片
仿制 62015-10-
08
成都恒瑞制药有限
公司
制证完毕－已发批件
2016-08-01 批准临床
CYHS1501141
依折麦布片
仿制 62015-10-
13
昆药集团股份有限
公司
制证完毕－已发批件
2016-08-04 批准临床
CXHL1500140
依折麦布 新药 3.12015-10-
19
山西普德药业股份有限公司
制证完毕－已发批件
2016-08-01 批准临床
CXHL1500825
依折麦布 新药 3.12015-10-
26
山东孔府制药有限
公司
制证完毕－已发批件
2016-11-23 批准临床
CYHS1501053
依折麦布片
仿制 62015-11-
13
远大医药（中国）有限公司
制证完毕－已发批件
2016-08-01 批准临床
CYHS1500775
依折麦布片
仿制 62015-11-
27
杭州民生药业有限
公司
制证完毕－已发批件
2016-07-21 批准临床
CXHL1502023
依折麦布 新药 3.12015-12-
01
南京优科制药有限
公司
制证完毕－已发批件
2017-09-20 批准临床
CYHS1500452
依折麦布片
仿制 62015-12-
17
江苏亚邦强生药业有限公司
制证完毕－已发批件
2016-05-19 批准临床
CYHS1500130
依折麦布片
仿制 62015-12-
24
山西普德药业股份有限公司
制证完毕－已发批件
2016-08-01 批准临床
CYHS1501026
依折麦布片
仿制 62016-01-
05
华北制药股份有限
公司
制证完毕－已发批件
2016-10-27 批准临床
CXHL1501360
依折麦布 新药 3.12016-01-
05
华北制药华胜有限
公司
制证完毕－已发批件
2016-10-27 批准临床
CYHS1501064
依折麦布片
仿制 62016-02-
16
北京四环制药有限
公司
制证完毕－已发批件
2016-05-19 批准临床
CXHL1502357
依折麦布 新药 3.12016-02-
16
沈阳沃森药物研究
所
制证完毕－已发批件
2017-02-13 批准临床
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 15/71
受理号码 药品名称 申请类型 注册分类 承办日期 企业名称 办理状态 状态开始日期 审批结论
CXHL1502246
依折麦布胶囊
新药 52016-03-
11
海南通用三洋药业有限公司
制证完毕－已发批件
2016-10-27 批准临床
CXHL1502013
依折麦布 新药 3.12016-04-
15
南京华威医药科技开发有限
公司
制证完毕－已发批件
2017-04-17 批准临床
CYHS1500942
依折麦布片
仿制 62016-04-
20
山东新时代药业有
限公司
制证完毕－已发批件
2016-10-27 批准临床
CYHS1500678
依折麦布片
仿制 62016-06-
29
山东孔府制药有限
公司
制证完毕－已发批件
2016-11-23 批准临床
JYHB1601289
依折麦布片
补充申请2016-09-
23
默沙东研发（中
国）有限公司
制证完毕－已发批件
2017-01-04 批准临床
JYHB1700669
依折麦布片
补充申请2017-05-
13
默沙东研发（中
国）有限公司
制证完毕－已发批件
2017-07-06 批准补充
JYHF1700046
依折麦布片
补充申请2017-06-
16
杭州默沙东制药有
限公司
制证完毕－已发批件
2017-07-11
申请类型
数量
新药 进口 仿制 补充申请0
10
20
30
40
50
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 16/71
药品名称 标准来源 页码 查看全文/文件下载
依折麦布片 JX20030223
Ezetimibe USP39-NF34 查看
药品名称 来源 更新时间 操作
剂型
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原料药 片剂 胶囊0
10
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承办日期
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2003 2005 2007 2009 2011 2012 2013 2014 2015 2016 20170
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药品标准(2条)
药品说明书(23条) 隐藏
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 17/71
依折麦布片 默沙东（中国）有限公司/MSD PHARMA (SINGAPORE) PTE. LTD. 查看全文下载1
依折麦布片 默沙东（中国）有限公司/MSD PHARMA (SINGAPORE) PTE. LTD. 下载1
ZETIA MSD INTL GMBH 2002-10-25
ZETIA MSD INTL GMBH 2004-07-28
ZETIA MSD INTL GMBH 2005-03-29
ZETIA MSD INTL GMBH 2006-03-22
ZETIA MSD INTL GMBH 2006-11-06
ZETIA MSD INTL GMBH 2007-12-14
ZETIA MSD INTL GMBH 2008-02-14
ZETIA MSD INTL GMBH 2008-06-12
ZETIA MSD INTL GMBH 2009-07-23
ZETIA MSD INTL GMBH 2009-07-23
ZETIA MSD INTL GMBH 2011-08-12
ZETIA MSD INTL GMBH 2012-01-25
ZETIA MSD INTL GMBH 2004-07-28
ZETIA MSD INTL GMBH 2004-07-28
ZETIA MSD INTL GMBH 2005-03-10
ZETIA MSD INTL GMBH 2006-05-24
ZETIA MSD INTL GMBH 2006-01-27
ZETIA MSD INTL GMBH 2006-03-22
ZETIA MSD INTL GMBH 2008-06-12
ZETIA MSD INTL GMBH 2009-02-04
ZETIA MSD INTL GMBH 2014-10-30
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
PegylatedInterferonAlone orinCombination WithEzetimibeforPatientsWithChronicHepatitisD
Drug:Pegylatedinterferon
alfa;Drug:Ezetimibe
Active, notrecruiting
Hepatitis D,Chronic
Phase 2 2016-01-01
全球临床试验情况(254条) 隐藏
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 18/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
EzetimibeforPatientsWithChronicHepatitisD
Drug:Ezetimibe RecruitingChronic Hepatitis
DPhase 2 Pakistan 2017-01-01
Evaluation of theEfficacyandSafety ofBempedoic Acid(ETC-1002)180mg,Ezetimibe10mg,andAtorvastatin 20 mgTripletTherapyinPatientsWithElevatedLDL-C
Drug:Bempedoicacid
180mg;Drug:Ezetimibe
10mg;Drug:Atorvastatin
20mg;Other:Placebo
RecruitingHypercholesterol
emiaPhase 2 United States 2017-01-01
RAndomizedComparison ofEfficacyandSafety ofLipid-lowerINGWithStatinMonotherapyVersusStatin/EzetimibeCombination forHigh-riskCardiovascularDiseases(RACINGTrial)
Drug:Rosuvastatin;Drug:Rosuvastatin
plus ezetimibeRecruiting
CardiovascularDiseases;Cerebro
vascularDisease;Peripher
alAtherosclerotic
Disease
Korea,Republic of
2017-03-15
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 19/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Evaluation of theEfficacyandSafety ofBempedoic Acid(ETC-1002) asAdd-ontoEzetimibeTherapyinPatientsWithElevatedLDL-C(CLEARTranquility)
Drug:Bempedoicacid;Drug:Ezetimibe;
Other:PlaceboRecruiting
Hypercholesterolemia;Atheroscler
osis;StatinAdverse Reaction
Phase 3 United States 2016-12-01
Evaluation ofCoronaryArteryPlaqueVolumeProgression/Regression andSafety ofAlirocumab inJapanesePatientsHospitalized forAcuteCoronarySyndrome WithHypercholesterolemia
Drug:alirocumabSAR236553;Drug:atorvastatin;Drug:rosuvastatin;Drug:fenofibrate;Drug:bezafibrate;Drug:ezetimibe;Drug:antiplatelets;Drug:a
nticoagulants
Recruiting
Hypercholesterolemia;AcuteCoronary
Syndrome
Phase 4 Japan 2016-11-01
Ezetimibeas a SafeandEfficaciousTreatment forChronicHepatitisC
Drug:20mgezetimibe;Drug:Plac
ebo;Drug:40mgezetimibe
Not yetrecruiting
Chronic HepatitisC
Phase 2 United States 2017-01-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 20/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Effect ofLipidModifying Drugson HDLFunctioninPatientsWithHyperlipidemia
Drug:Atorvastatin 20mg;Drug:Cholestyra
mine 8g;Drug:Omega-3
2g;Drug:Concurrentwith Atorvastatin 5mg + Ezetimibe 10
mg;Behavioral:Lifestyle modification
Recruiting HyperlipidemiaKorea,
Republic of2013-06-01
An 8-WeekDose-FindingStudy toEvaluatetheEfficacyandSafety ofAlirocumab inChildrenandAdolescents WithHeterozygousFamilialHypercholesterolemia
Drug:alirocumabSAR236553
(REGN727);Drug:statins;Drug:ezetimibe;Drug:cholestyramine;
Drug:fenofibrate;Drug:omega-3 fatty
acids;Drug:nicotinicacid
RecruitingHypercholesterol
aemiaPhase 2
UnitedStates;Canada;Australia;Fr
ance;Netherlands;Norway;R
ussianFederation;So
uthAfrica;Spain;S
weden
2016-09-01
Effectiveness ofTreatment ofHypercholesterolemia WithRosuvastatin andEzetimibe
Drug:Rosuvastatinand Ezetimibe
morning or eveningadministration
RecruitingHypercholesterol
emiaPhase 4 Poland 2016-03-01
Study ofEzetimibeforChronicHepatitisC Virus(HCV)Infectionin LiverTransplantCandidates (EZE-2)
Drug:Ezetimibe Recruiting Hepatitis C Phase 4 Chile 2013-06-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 21/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
A ClinicalTrial toComparetheEfficacyandSafety ofaCombinationTherapyofEzetimibeandRosuvastatin VersusMonotherapy ofRosuvastatin inHypercholesterolemiaPatients(I-ROSETTEStudy)
Drug:Rosuvastatin;Drug:Ezetimibe
CompletedHypercholesterol
emiaPhase 3
Korea,Republic of
2016-04-01
A ClinicalTrial toAssessthe LongTermSafetyandTolerability of MK-0653H inJapaneseParticipants WithHypercholesterolemia (MK-0653H-833)
Drug:Ezetimibe;Drug:Rosuvastatin
Active, notrecruiting
Hypercholesterolemia;Familial
Hypercholesterolemia
Phase 3 2016-05-18
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 22/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
A Studyof theEfficacyandSafety ofMK-0653H inJapaneseParticipants WithHypercholesterolemia (MK-0653H-832)
Drug:Ezetimibe 10mg;Drug:Rosuvastati
n 2.5mg;Drug:Placebo forEzetimibe;Drug:Placebo for Rosuvastatin
CompletedHypercholesterol
emiaPhase 3 2016-06-01
A StudytoComparethePharmacokineticsof DP-R207 inComparison toEachComponentAdministered Alone
Drug:DP-R207;Drug:Rosuvastatin;Drug:Ezetimibe
CompletedHealthy
VolunteersPhase 1 2014-12-01
Evaluation ofAlirocumab VersusEzetimibeon Top ofStatin inAsia inHighCardiovascular RiskPatientsWithHypercholesterolemia
Drug:alirocumabSAR236553
(REGN727);Drug:placebo for
alirocumab;Drug:ezetimibe;Drug:placebo
forezetimibe;Drug:atorvastatin;Drug:rosuvastatin;Drug:simvasta
tin
RecruitingHypercholesterol
emiaPhase 3
China;India;Thailand
2016-07-01
Randomized TrialComparingColesevelam vs.Ezetimibe
Drug:Colesevelam;Drug:Ezetimibe
RecruitingType 2 Diabetes
MellitusPhase 4 Canada 2016-01-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 23/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
EfficacyandSafety ofAlirocumab VersusUsualCare onTop ofMaximallyToleratedStatinTherapyinPatientsWithType 2DiabetesandMixedDyslipidemia(ODYSSEYDM-Dyslipidemia)
Drug:ALIROCUMABSAR236553
(REGN727);Drug:placebo;Drug:statins;Drug:ezetimibe;Drug:fenofibrate;Drug:nicoti
nicacid;Drug:omega-3
fatty acids
Active, notrecruiting
Dyslipidemia Phase 4
UnitedStates;Australia;Brazil;Finland;Germany;Israel;Italy;Ku
wait;Lebanon;Norway;Sweden;Switzerland;Turkey;Unit
ed ArabEmirates;United Kingdom
2016-03-01
GoalAchievement AfterUtilizingan Anti-PCSK9Antibodyin StatinIntolerantSubjects-4
Biological:Evolocumab;Drug:Ezetimibe;Biological:Evolocumab
;Drug:Ezetimibe
RecruitingHypercholesterol
emiaPhase 3 Japan 2016-02-27
EzetimibeandAtorvastatinTherapyon TCFA
Drug:Ezetimibe andAtorvastatin;Drug:At
orvastatinRecruiting
Coronary ArteryDisease
Phase 4 China 2015-10-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 24/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
EfficacyandSafety ofAlirocumab inPatientsWithHypercholesterolemia NotAdequatelyControlled WithNon-statinLipidModifying Therapyor theLowestStrengthof Statin
Drug:alirocumabSAR236553
(REGN727);Drug:placebo;Drug:atorvastatin;Drug:fenofibrate;Drug:bezafibrate;Dr
ug:ezetimibe
Active, notrecruiting
Hypercholesterolaemia
Phase 3 Japan 2015-11-30
A ClinicalTrial toAssesstheEfficacyandSafety ofMK-0653C inJapaneseParticipants WithHypercholesterolemia (MK-0653C-383)
Drug:Ezetimibe 10mg;Drug:Atorvastati
n 10mg;Drug:Placebo for
Ezetimibe 10 mgtablet;Drug:Placebofor Atorvastatin 10
mgcapsule;Behavioral:D
iet control/DailyExercise
CompletedHypercholesterol
emiaPhase 3 2015-09-01
EfficacyandSafety ofSimvastatin-ezetimibeCombinationTherapyAmongPatientsWith SLE
Drug:Ezetimibe+Simvastatin DrugCombination
Enrolling byinvitation
AtherosclerosisEarly
Phase 1China 2015-04-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 25/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
A Studyof the PKInteraction of CXA-10 WithPravastatin andVytorin®inHealthyMales
Drug:CXA-10;Drug:pravastatin;
Drug:Vytorin®(combination ofsimvastatin and
ezetimibe)
CompletedAcute Kidney
InjuryPhase 1 United States 2015-12-01
CellularEffect ofCholesterol-LoweringPrior toProstateRemoval
Drug:ezetimibe10mg-simvastatin
40mgRecruiting Prostate Cancer
EarlyPhase 1
United States 2015-10-01
CKD-391PharmacokineticStudyPhase I
Drug:CKD-391;Drug:Atrovastati
n and Ezetimibecombination therapy
Completed Healthy Phase 1 2015-08-01
CKD-391PharmacokineticStudy
Drug:CKD-391;Drug:Atrovastati
n and Ezetimibecombination therapy
Completed Healthy Phase 1Korea,
Republic of2015-07-01
ClinicalTrial toEvaluatetheEfficacyandSafety ofCKD-391
Drug:Atorvastatin10mg,
Ezetimibe10mg;Drug:Atorvastatin10mg,
Ezetimibeplacebo;Drug:Atorva
statin20mg,Ezetimibe10mg;Drug:Atorvastatin20mg,
Ezetimibeplacebo;Drug:Atorva
statin40mg,Ezetimibe10mg;Drug:Atorvastatin40mg,Ezetimibe placebo
Completed Hyperlipidemia Phase 3Korea,
Republic of2015-03-01
Effects ofSimvastatin andEzetimibeonCardiovascular RiskMarkersinPatientsWithDyslipidemia
Drug:Simvastatin;Drug:Ezetimibe;Drug:Si
mvastatin +Ezetimibe
Completed Dyslipidemia 2009-01-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 26/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
toInvestigate thePharmacokineticInteractions andSafetyBetweenRosuvastatin andEzetimibeinHealthyMaleVolunteers
Drug:Crestor+Ezetrol;Drug:Ezetrol;Drug:C
restorCompleted Healthy Phase 1 2014-12-01
CKD-391DDI :Atorvastatin andEzetimibeinHealthyVolunteers
Drug:1(Lipitor®);Drug:1(Ezetrol®);Drug:1
(Lipitor®,Ezetrol®);Drug:2
(Ezetrol®);Drug:2(Lipitor®,
Ezetrol®);Drug:2(Lipitor®);Drug:3(Lip
itor®,Ezetrol®);Drug:3(Lipitor®);Drug:3(Ezetrol®);Drug:4
(Lipitor®);Drug:4(Lipitor®,
Ezetrol®);Drug:4(Ezetrol®);Drug:5(Ezetrol®);Drug:5(Lipitor®);Drug:5
(Lipitor®,Ezetrol®);Drug:6(Lip
itor®,Ezetrol®);Drug:6(Ezetrol®);Drug:6
(Lipitor®)
Completed Healthy Phase 1Korea,
Republic of2014-11-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 27/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
A StudyofEvacetrapib(LY2484595) inCombination WithAtorvastatin inJapaneseParticipants WithPrimaryHypercholesterolemia
Drug:Evacetrapib;Drug:Ezetimibe;Drug:Atorvastatin;Drug:Plac
ebo
TerminatedHypercholesterol
emiaPhase 3 Japan 2015-01-01
TheEfficacyandSafety ofaCombinationTherapyofRosuvastatin andEzetimibeVersusMonotherapy ofRosuvastatin inHypercholesterolemiaPatients
Drug:Rosuvastatin/Ezetimibe
Unknownstatus
Hypercholesterolemia
Phase 3Korea,
Republic of2014-07-01
Ezetimibe-UrsodiolCombinationTherapyonBiomarkers of LiverFunctionandSterolBalanceinSubjectsWithNAFLD
Drug:EZ-Ursocombination therapy
TerminatedNonalcoholic
Fatty LiverDisease (NAFLD)
Phase 2 United States 2014-09-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 28/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Effect ofanInhibitorofCholesterolAbsorption onVitamin DLevels
Drug:Ezetimibe;Drug:Cholecalciferol;Othe
r:PlaceboCompleted
Vitamin DDeficiency
Phase 4 Brazil 2014-10-01
A StudyofEvacetrapib(LY2484595) inParticipants WithHighCholesterol
Drug:Evacetrapib;Drug:Atorvastatin;Drug:Ezetimibe;Drug:Plac
ebo
Terminated Hyperlipidemia Phase 3United
States;PuertoRico
2014-10-01
Rosuvastatin forReduction ofMyocardialDamageandSystemicInflammationDuringCoronaryAngioplasty
Drug:Atorvastatin;Drug:Rosuvastatin;Drug:Rosuvastatin;Drug:Ezetimibe;Drug:plac
ebo
TerminatedStable CoronaryArtery Disease
Undergoing PCIPhase 3 Italy 2010-05-01
StatinsforOxidativeStressandMitochondrialFunctioninDiabeticPolyneuropathy
Drug:calcinedmagnesia;Drug:Ezetimibe/simvastatin;Dr
ug:Rosuvastatin
CompletedOxidative
Stress;DiabeticPolyneuropathy
Phase 2 Mexico 2012-02-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 29/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Investigating thePharmacokineticDrugInteractionsBetweenRosuvastatin andEzetimibe
Drug:Rosuvastatin20mg;Drug:Ezetimib
e10mg;Drug:Rosuvast
atin 20mg +Ezetimibe 10mg
Completed Healthy Phase 1Korea,
Republic of2014-06-01
PilotStudy ofEzetimibeforChronicHepatitisC Virus(HCV)Infection
Drug:Ezetimibe RecruitingChronic Hepatitis
CPhase 1 Chile 2013-10-01
TheImpact ofEzetimibeonBiochemicalMarkersofCardiovascular Riskin KidneyTransplant Patients
Drug:Ezetimibe CompletedDyslipidemia;Tra
nsplantsPhase 4 Slovenia 2014-04-01
PlantSterolsEffect onPreviousStatinTherapy
Other:Ezetimibe +plant
sterols;Drug:Ezetimibe;Dietary
Supplement:Plantsterols
CompletedCoronary Artery
Disease
Phase2/Phase
3Brazil 2006-10-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 30/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
DoseRangingStudy OfBococizumab (PF-04950615; RN316)InHypercholesterolemicJapaneseSubjects
Drug:Bococizumab(PF-
04950615;RN316);Drug:Bococizumab
(PF-04950615;RN316);Dr
ug:Bococizumab(PF-
04950615;RN316);Drug:Placebo;Drug:Ezetimibe;Drug:Bocociz
umab (PF-04950615;RN316);Dr
ug:Bococizumab(PF-
04950615;RN316);Drug:Bococizumab
(PF-04950615;RN316);Dr
ug:Placebo
CompletedHypercholesterol
emiaPhase 2 Japan 2014-03-01
ComparethePharmacokineticsof NVP-1205 andCoadministrationofRosuvastatin andEzetimibe
Drug:NVP-1205;Drug:rosuvasta
tin and ezetimibeCompleted Dyslipidemia Phase 1
Korea,Republic of
2014-02-01
GoalAchievement AfterUtilizingan Anti-PCSK9Antibodyin StatinIntolerantSubjects-3
Drug:Part A,Atorvastatin;Other:P
art A, Placebo(administered
orally);Drug:Part B,Evolocumab;Other:P
art B, Placebo(administered
orally);Drug:Part B,Ezetimibe;Other:Part
B, Placebo(administered
subcutaneously);Drug:Part C,
Evolocumab
Active, notrecruiting
Hyperlipidemia Phase 3
UnitedStates;Canada;Australia;Cz
echRepublic;Denmark;France;
Germany;Italy;Netherlands;
NewZealand;Nor
way;SouthAfrica;United
Kingdom
2013-12-01
Cholesterol-loweringEffects ofnutraceuticaLsVersusEzetimibein Statin-intolerantPatients
Drug:Ezetimibe;Dietary
Supplement:Nutraceuticals
Not yetrecruiting
Coronary ArteryDisease
Phase 4 Italy 2014-01-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 31/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
EzetimibeVersusPlaceboin theTreatment of Non-alcoholicSteatohepatitis
Drug:Ezetimibe CompletedNon AlcoholicSteatohepatitis
Phase 2 United States 2013-01-01
GoalAchievement AfterUtilizingan Anti-PCSK9Antibodyin StatinIntolerantSubjects-2
Biological:Evolocumab;Drug:Placebo to
Evolocumab;Drug:Ezetimibe;Drug:Placeb
o to Ezetimibe
Completed Hyperlipidemia Phase 3
UnitedStates;Canada;Australia;Belgium;Denmark;France;Germany;Hong
Kong;Netherlands;Poland;S
outhAfrica;Spain;Switzerland;United Kingdom
2013-01-01
LDL-CAssessment WithPCSK9MonoclonalAntibodyInhibitionCombined WithStatinTherapy-2
Biological:Evolocumab;Drug:Ezetimibe;D
rug:Placebo toEvolocumab;Drug:Pl
acebo toEzetimibe;Drug:Atorvastatin;Drug:Rosuvastatin;Drug:Simvast
atin
Completed Hyperlipidemia Phase 3
UnitedStates;Canada;Australia;Belgium;Czech
Republic;Denmark;France;
Germany;Hong
Kong;Hungary;Italy;Korea,
Republicof;Mexico;Netherlands;Rus
sianFederation;So
uthAfrica;Spain;Sweden;Switzerland;Taiwan;
UnitedKingdom
2013-01-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 32/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
MonoclonalAntibodyAgainstPCSK9 toReduceElevatedLDL-C inSubjectsCurrentlyNotReceivingDrugTherapyfor EasingLipidLevels-2
Biological:Evolocumab;Drug:Ezetimibe;Biological:Placebo to
Evolocumab;Other:Placebo to Ezetimibe
Completed Hyperlipidemia Phase 3
UnitedStates;Canada;Australia;Belgium;Denmark;France;Korea, Republic
of;SouthAfrica;Taiwan;
Turkey
2013-01-01
Study ofAlirocumab(REGN727/SAR236553)added-ontoRosuvastatin VersusOtherLipidModifyingTreatments (LMT)(ODYSSEYOPTIONSII)
Drug:Alirocumab;Drug:Rosuvastatin;Drug:Ezetimibe;Drug:Pla
cebo
CompletedHypercholesterol
emiaPhase 3
UnitedStates;Canada;Australia;France;Germany;Italy;Mexico;Spain;United
Kingdom
2012-11-01
Study oftheEfficacyandSafety ofAlirocumab(REGN727/SAR236553) inCombination WithOtherLipid-modifyingTreatment (LMT)(ODYSSEYOPTIONSI)
Drug:Alirocumab;Drug:Atorvastatin;Drug:Ezetimibe;Drug:Rosuvastatin;Drug:Place
bo
CompletedHypercholesterol
emiaPhase 3
UnitedStates;Canada;Australia;France;Germany;Italy;Mexico;Spain;United
Kingdom
2012-10-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 33/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Effect ofAlirocumab(SAR236553/REGN727)Administered onTop ofEzetimibeorFenofibrate onLipidProfiles inHealthySubjects
Drug:Alirocumab;Drug:Ezetimibe;Drug:E
zetimibePlacebo;Drug:Fenofi
brate
CompletedHypercholesterol
emiaPhase 1 France 2012-11-01
Study ofAlirocumab(REGN727/SAR236553) inPatientsWithPrimaryHypercholesterolemia andModerate, High, orVery HighCardiovascular (CV)Risk, WhoAreIntolerantto Statins(ODYSSEYALTERNATIVE)
Drug:Atorvastatin;Drug:Ezetimibe;Drug:Alirocumab;Drug:Plac
ebo
Active, notrecruiting
Hypercholesterolemia
Phase 3
UnitedStates;Canada;Austria;France;Israel;Italy;Norway;Unite
d Kingdom
2012-09-01
LifestyleVersusEzetimibePlusLifestyleinPatientsWithNon-alcoholicSteatohepatitis
Drug:Ezetimibe;Behavioral:Lifestyle
Unknownstatus
•Non-alcoholicSteatohepatitis
(NASH)Phase 4 Italy 2013-10-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 34/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Evaluation of ETC-1002,Ezetimibe, and theCombination inHypercholesterolemicPatients
Drug:ETC-1002;Drug:Ezetimibe
CompletedHypercholesterol
emiaPhase 2 United States 2013-09-01
EarlyEffects ofIntensiveLipidLoweringTreatment WithEzetimibe/Simvastatin(Vytorin®)Assessedby VirtualHistology-IntravascularUltrasound (VH-IVUS) andOpticalCoherenceTomography (OCT)on PlaqueCharacteristics inPatientsWithAcuteCoronarySyndrome
Device:ZotalolimusEluting
Stent;Device:Everolimus eluting
stent;Drug:Ezetimibe10mg & Simvastatin40mg;Drug:Pravasta
tin 20mg
CompletedAcute Coronary
SyndromePhase 4
Korea,Republic of
2009-11-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 35/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Effects ofSelectiveInhibitionofCholesterolAbsorption WithEzetimibeonIntestinalCholesterolHomeostasis inDyslipidemic MenWithInsulin-resistance- a PilotStudy
Drug:Ezetimibe;Drug:Placebo
CompletedMetabolic
Syndrome XPhase 3 Canada 2013-06-01
EfficacyandSafety ofAlirocumab(SAR236553/REGN727)VersusEzetimibeinPatientsWithHypercholesterolemia
Drug:Alirocumab;Drug:Ezetimibe;Drug:Pl
acebo (forAlirocumab);Drug:Pl
acebo (forEzetimibe)
CompletedHypercholesterol
emiaPhase 3
UnitedStates;Belgiu
m;Finland;Netherlands
2012-07-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
EfficacyandSafety ofAlirocumab(SAR236553/REGN727)VersusEzetimibeon Top ofStatin inHighCardiovascular RiskPatientsWithHypercholesterolemia(ODYSSEYCOMBOII)
Drug:Alirocumab;Drug:Placebo (for
alirocumab);Drug:Ezetimibe;Drug:Placeb
o (forezetimibe);Drug:Lipi
d ModifyingTherapy (LMT)
CompletedHypercholesterol
emiaPhase 3
UnitedStates;Canada;Denmark;France;Hungary;Israel;Korea,
Republicof;Russian
Federation;South
Africa;Ukraine
2012-08-01
A Studyof theEffect ofEzetimibeonGlucoseMetabolism in Type2DiabeticsWithHypercholesterolemia(P06541)
Drug:Ezetimibe;Drug:Placebo
CompletedHypercholesterol
emiaPhase 4 2012-07-02
Physiological Studyof HumanCholesterolMetabolism andExcretion
Drug:Ezetimibe Completed
Coronary HeartDisease;Cardiova
scularDisease;Dyslipidemia;Disorder of
CholesterolMetabolism
Phase 1 United States 2014-01-01
Acotral®VersusZetia®EzetimibeBioequivalanceStudy.
Drug:10mgEzetimibe;Drug:10
mg Ezetimibe - washout period
CompletedHypercholesterol
aemiaPhase 1 India 2012-01-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
A StudytoEvaluatetheEfficacyandSafety ofVytorinVersusStandardTreatment of OtherStatins inModerate,Moderately Highand HighRiskParticipants (MK-0653A-406)
Drug:Ezetimibe/simvastatin;Drug:Other
StatinWithdrawn Dyslipidemia Phase 4 2013-03-01
SitosterolemiaMetabolism
Drug:EzetimibeActive, notrecruiting
Sitosterolemia Canada 2012-04-01
DurableEffect ofPCSK9AntibodyCompARed wiThplacEboStudy
Biological:Evolocumab;Biological:Placebo;Drug:Atorvastatin;Drug:Ezetimibe;Othe
r:Diet Only
CompletedHypercholesterol
emiaPhase 3
UnitedStates;Canada;Australia;Austria;Belgium;
CzechRepublic;Denmark;Hungary;South Africa
2012-01-01
EzetimibeVersusNutraceuticals inStatin-intolerantPatients
Drug:Ezetimibe;Drug:Nutraceuticals
Unknownstatus
Coronary ArteryDisease
Phase 4 Italy 2013-01-01
Effects onNF-κBActivity:HighDoseSimvastatin VersusCombinationTherapyWithEzetimibe
Drug:Simvastatin 80mg;Drug:Sim10/Eze
10;Drug:PlaceboCompleted
Type 2Diabetes;Inflam
mationGermany 2004-04-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
EfficacyandSafety ofFDC inHigh RiskPatientsWithPrimaryHypercholesterolemia orMixedDyslipidemia
Drug:Rosuvastatin10 mg + Ezetimibe
10 mg andRosuvastatin 20 mg+ Ezetimibe 10 mg,
according withtitration.;Drug:Simva
statin 20 mg +Ezetimibe 10 mg
and Simvastatin 40mg + Ezetimibe 10mg, according with
titration.
CompletedHypercholesterolemia;Dyslipidemi
aPhase 3 Brazil 2013-03-01
EzetimibeInAdditionToAtorvastatinTherapyOn ThePlaqueComposition InPatientsWithAcuteMyocardialInfarction.
Drug:Ezetimibe;Drug:Placebo
Completed
ST-SegmentElevation
MyocardialInfarction
Phase 4 Denmark 2011-06-01
Effect ofEzetimibeorSimvastatin or Bothon LowDensitiyLipoprotein -Subfractions inPatientsWithType 2Diabetes
Drug:ezetimibe;Drug:simvastatin;Drug:Ez
etimibe10/Simvastatin 20
Completed
Diabetes MellitusType
2;Hypercholesterolemia
Phase 4 Germany 2007-11-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Effect ofEzetimibeTreatment on Low-densityLipoproteinCholesterol (LDL-C)Levels inParticipants WithCoronaryHeartDisease(CHD)AlreadyTreatedWith aStatin(MK-0653A-205 AM1)
Drug:Ezetimibe CompletedHypercholesterol
emia2009-05-01
MonoclonalAntibodyAgainstPCSK9 toReduceElevatedLow-densityLipoproteinCholesterol (LDL-C)in AdultsCurrentlyNotReceivingDrugTherapyfor EasingLipidLevels
Biological:Evolocumab;Drug:Ezetimibe;O
ther:Placebo toEvolocumab
Completed Hyperlipidemia Phase 2
UnitedStates;Canada;Australia;Belgium;Denma
rk
2011-07-01
GoalAchievement AfterUtilizingan Anti-PCSK9Antibodyin StatinIntolerantSubjects
Biological:Evolocumab;Drug:Ezetimibe;O
ther:Placebo toEvolocumab
Completed Hyperlipidemia Phase 2
UnitedStates;Canada;Australia;Belgium;Denmark;Finland;Spa
in;Sweden
2011-07-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
A StudytoEvaluatetheEffectiveness ofEzetimibe/Atorvastatin 10mg/40mgCombination TabletCompared toMarketedEzetimibe10 mgandAtorvastatin 40 mgTablets inParticipants WithHighCholesterol (MK-0653C-190 AM1)
Drug:Atorvastatin;Drug:Ezetimibe;Drug:Ezetimibe/atorvastati
n;Drug:Placebo toatorvastatin;Drug:Pla
cebo toezetimibe;Drug:Plac
ebo toezetimibe/atorvastat
in
CompletedHypercholesterol
emiaPhase 3 2011-09-01
A StudytoEvaluatetheEffectiveness ofEzetimibe/Atorvastatin 10mg/20mgCombination TabletCompared toMarketedEzetimibe10 mgandAtorvastatin 20 mgTablets inParticipants WithHighCholesterol (MK-0653C-185 AM1)
Drug:Atorvastatin;Drug:Ezetimibe;Drug:Ezetimibe/atorvastati
n;Drug:Placebo toatorvastatin;Drug:Pla
cebo toezetimibe;Drug:Plac
ebo toezetimibe/atorvastat
in
CompletedHypercholesterol
emiaPhase 3 2011-09-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Pleiotropism ofStatinTherapyin HighDoseVersusLow DoseCombined WithEzetimibe
Drug:simvastatin,combined with
simvastatinezetimibe, placebo
Unknownstatus
EndothelialFunction
Brazil 2010-03-01
A StudytoDetermine theBioequivalence ofSCH900068Compared toMarketedProducts(ProtocolNo.P07551)
Drug:Ezetimibe;Drug:Ezetimibe/atorvasta
tin 10mg/10mgFDC;Drug:Atorvastat
in10mg;Drug:Atorvast
atin80mg;Drug:Ezetimib
e/atorvastatin10mg/80mg FDC
Completed Hyperlipidemia Phase 1 2011-02-01
A StudytoInvestigate theSafety,Tolerability,PharmacokineticsandPharmacodynamicsofAdministeringMultipleOralDoses ofGSK1292263Aloneand WithAtorvastatin
Drug:10mgatorvastatin;Drug:80
mgatorvastatin;Drug:GS
K1292263Placebo;Drug:100mgGSK1292263;Drug:3
00mgGSK1292263;Drug:8
00mgGSK1292263;Drug:1
0mgezetimibe;Other:Was
hout
Completed Dyslipidaemias Phase 2 United States 2010-09-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Study toComparethe Effectof Vytorin(Simvastatin/Ezetimibe)10/20mgVersusAtorvastatin 20mgonApoB/ApoA1 RatioinSubjectsWithDiabetes
Drug:simvastatin/ezetimibe;Drug:atorvas
tatin 20mg
Unknownstatus
Type 2 DiabetesMellitus Without
InsulinTreatment
Phase 4Korea,
Republic of2010-09-01
EfficiencyofRosuvastatin Versusthe FixedCombination ofEzetimibe/Simvastatin inOutpatients
Completed Dyslipidemia Mexico 2009-04-01
MK0653Cin HighCardiovascular RiskPatientsWithHighCholesterol (SwitchStudy)(MK-0653C-162)
Drug:ezetimibe 10mg;Drug:atorvastatin;Drug:Comparator:
rosuvastatin
CompletedHypercholesterol
emiaPhase 3 2010-07-01
Effect ofSimvastatin andEzetimibeon LipidandInflammation
Drug:Simvastatin;Drug:Ezetimibe;Drug:C
ombinationSimvastatin plus
Ezetimibe
Completed
Prediabetes;Hypercholesterolemia;Inflammation;C
ardiovascularRisk
Brazil 2005-06-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Atorvastatin PlusEzetimibeonCoronaryPlaqueProgression
Drug:atorvastatin;Drug:atorvastatin plus
ezetimibe
Unknownstatus
Coronary ArteryDisease
Phase 4 China 2010-01-01
AnObservationalFollow-Up Studyof theIncidenceof CancerandMortalityinPatientsFrom theSEAS(Simvastatin andEzetimibein AorticStenosis)Trial (MK-0653A-043-10)
Completed Cancer 2010-03-01
TheEffects ofEzetimibeonCoronaryPlaqueVolumeinPatientsWithAcuteCoronarySyndrome
Drug:EzetimibeUnknown
statusCoronary Artery
DiseasePhase 4 Japan 2010-10-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
PlaqueREgression WithCholesterolAbsorptionInhibitororSynthesisInhibitorEvaluatedbyIntraVascularUltraSound
Drug:Combinationtherapy with Lipitor[Atorvastatin] and
Zetia[Ezetimibe];Drug:Lipi
tor (Atorvastatin)monotherapy
CompletedHypercholesterol
emia;CoronaryArtery Disease
Phase 4 Japan 2010-01-01
PlateletFunctioninDiabeticPatientsWith andWithoutRenalImpairment, andtheEffects ofLipidLoweringTreatment
Drug:Ezetimibe CompletedDiabetes
Mellitus;RenalImpairment
Phase 4 Sweden 2006-01-01
Effect ofEzetimibeonOxidizedLow-densityLipoprotein (LDL)Cholesterol
Drug:ezetimibe CompletedCoronary ArteryDisease;Diabetes
Phase 4 Lebanon 2008-09-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Effects ofEzetimibe,Simvastatin, andVytorinonReducingL5 aSubfraction of LDLinPatientsWithMetabolicSyndrome.
Drug:Simvastatin;Drug:Vytorin;Drug:Placebo;Drug:Ezetimibe
Unknownstatus
MetabolicSyndrome
Phase 4 United States 2009-10-01
Tolerability andLipidLoweringEffect ofWeekly/BiweeklyCrestor inStatinIntolerantPatientsTreatedWithZetia
Drug:Rosuvastatin;Drug:Ezetimibe
Unknownstatus
Hypercholesterolemia
Phase 4 United States 2009-09-01
EzetimibeinPatientsHypo-responsive toStatins
Drug:Ezetimibe;Drug:Atorvastatin
Terminated
HighCholesterol;Coro
nary ArteryDisease
Phase 3 United States 2009-09-01
CanCholesterolLoweringDrugsInfluenceCirculatingOmega-3Fatty AcidLevels
DietarySupplement:Flax
seed oil(ALA);Drug:Ezetimib
e
CompletedHypercholesterolemia;Hyperlipide
miaCanada 2009-07-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Comparison ofSimvastatin VersusSimvastatin/Ezetimibe onSmallDenseLow -DensityLipoprotein (LDL)
Drug:SIMVASTATIN40
mg;Drug:SIMVASTATIN/EZETIMIBE
10/10 mg
CompletedHypercholesterol
emiaPhase 4 Greece 2009-06-01
Effects onAtherosclerosisRegression ofEzetimibeorEzetimibePlusSimvastatin;EvaluatedbyFluorodeoxyglucosePositronEmissionTomography(FDG-PET)
Drug:Ezetrol(Ezetimibe);Drug:Vyt
orin (Ezetimibe +Simvastatin)
Withdrawn AtherosclerosisKorea,
Republic of2011-09-01
Post-marketingSurveillance of theSafety,Tolerability andEfficacyof Vytorin(Ezetimibe +Simvastatin) TabletAmongFilipinoPatients(StudyP05647)
Drug:Vytorin (R)(Ezetimibe +Simvastatin)
CompletedHypercholesterol
emia2006-11-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
AdditionofEzetimibe(Ezetrol®) toOngoingTherapyWithRosuvastatin(Crestor®) in HIVPositivePatientsNotReachingCholesterol Targets
Drug:Ezetimibe;Drug:Rosuvastatin
(standard care)Completed
Hypercholesterolemia;HIVInfections
Canada 2009-06-01
AdditiveEffect ofEzetimibeUponSimvastatin DuringMyocardialInfarction
Drug:Simvastatin;Drug:Ezetimibe-
SimvastatinCompleted
MyocardialInfarction
Phase 4 Brazil 2009-05-01
Effect ofDiabetesMellitusonCholesterolMetabolism
Drug:simvastatin orezetimibe
Completed
Type 1 DiabetesMellitus;Type 2
DiabetesMellitus;Hyperch
olesterolemia
United States 2008-08-01
2017/11/21 ezetimibe Drug Report
https://db.yaozh.com/report/detailwap/?id=Z5mYa2Zo 48/71
注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Evaluation ofEzetimibeandAtorvastatinCoadministrationVersusAtorvastatin orRosuvastatinMonotherapy inJapanesePatientsWithHypercholesterolemia(StudyP06027)(COMPLETED)
Drug:Ezetimibe;Drug:Atorvastatin;Drug:Atorvastatin;Drug:Ros
uvastatin
CompletedPrimary
Hypercholesterolemia
Phase 4 2009-02-01
PediatricStudy toEvaluatetheEfficacyandSafety ofEzetimibeMonotherapy inChildrenWithPrimaryHypercholesterolemia(P05522)
Drug:ezetimibe;Drug:Placebo
CompletedPrimary
Hypercholesterolemia
Phase 3 2009-05-01
Phytosterols,Ezetimibe, andCholesterolMetabolism
Drug:Phytosterol-Deficient Diet,
Ezetimibe 10 mg,Phytosterol Esters
Containing 2000 mgPhytosterols
CompletedHypercholesterol
emia;CoronaryHeart Disease
United States 2009-06-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Ezetimibe/Simvastatin (MK-0653A)VersusRosuvastatin VersusDoublingStatinDose inParticipants WithCardiovascularDiseaseandDiabetesMellitus(MK-0653A-133)(COMPLETED)
Drug:ezetimibe (+)simvastatin;Drug:sim
vastatin 40 mg oratorvastatin 20
mg;Drug:Rosuvastatin;Drug:atorvastatin
10 mg orsimvastatin 20 mg
CompletedCardiovascular
Disorder;Diabetes Mellitus
Phase 3 2009-04-01
Ezetimibe/SimvastatinCombination inProteinuricNephropathy
Drug:simvastatin;Drug:EZE/simvastatin;Drug:EZE/simvastati
n
Unknownstatus
Hypercholesterolemia;ChronicNephropathy
Phase 4 Italy 2008-11-01
CoadministrationofEzetimibeWithFenofibrate VersusPravastatinMonotherapy fortheTreatment ofHyperlipidaemia inHIV-infectedPatients
Drug:ezetimibe;Drug:fenofibrate;Drug:pra
vastatin
Unknownstatus
HIV;Hyperlipidemia;HIV
InfectionsPhase 4 Italy 2009-03-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Simvastatin With orWithoutEzetimibeandAtherothromboticBiomarkerAssessment
Drug:simvastatin;Drug:ezetimibe/simvas
tatinCompleted
MetabolicSyndrome
Phase 4 United States 2009-01-01
ThePostprAndialeNdothelialFunctionAfterCombination ofEzetimibeandsimvAstatin Study
Drug:Simvastatin;Drug:Simvastatin/Ezeti
mibeCompleted
MetabolicSyndrome
Phase 4Netherlands;
Spain2009-04-01
Fluvastatin 80 mgRet. vsCombination WithEzetimibe10 mg inPatientsWithHighCardiovascular Risk
Drug:fluvastatin;Drug:Fluvastatin plus
ezetimibeCompleted
Hypercholesterolemia
Phase 4 Austria 2005-09-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
PharmacokineticandPharmacodynamicInteractionsBetweentheCholesterol-loweringEzetimibeand theNon-nucleoside ReverseTranscriptaseInhibitorEfavirenzDuringChronicTreatment inHealthyVolunteers WithReferencetoIntestinalExpression ofCYP3A4,UGT1A1,ABCB1andABCC2
Drug:Ezetrol(ezetimibe) multiple
dose;Drug:Ezetrol(ezetimibe) multiple
dose and Sustiva(efavirenz) singledose;Drug:Ezetrol
(ezetimibe) andSustiva (efavirenz)
multipledose;Drug:Sustiva(efavirenz) single
dose
Completed
Pharmacokinetics;Drug
Interactions;Pharmacodynamics;In
testinalTransporterExpression
Phase 1 Germany 2009-03-01
Effects ofEzetimibeon theAbsorption ofOxidizedCholesterol
Drug:ezetimibe CompletedHypercholesterol
emiaPhase 4 United States 2006-06-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
A StudyofEzetimibeAddedOn toRosuvastatin VersusUpTitrationofRosuvastatin inPatientsWithHypercholesterolemia(MK0653-139)
Drug:Comparator:rosuvastatin 5 mg +
ezetimibe 10mg;Drug:Comparato
r: rosuvastatin 10mg;Drug:Comparato
r: rosuvastatin 10mg + ezetimibe 10
mg;Drug:Comparator: rosuvastatin 20
mg
CompletedHypercholesterol
emiaPhase 3 2008-11-01
Ezetimibe/Simvastatin (10mg/40mg) vs.theDoublingofAtorvastatin inHigh RiskParticipants (MK-0653A-134 AM1)(COMPLETED)
Drug:ezetimibe/simvastatin
10/40;Drug:atorvastatin 40
mg;Drug:atorvastatin 20 mg
CompletedHypercholesterol
emiaPhase 3 2008-11-01
Raltegravir andEzetimibePK Study
Drug:Raltegravir andezetimibe;Drug:Ezetimibe and raltegravir
Completed HIV Phase 1United
Kingdom2008-06-01
Evaluation of LDLCholesterol inPatientsSwitchedFrom 10to 5Milligrams of Zetia(Ezetimibe)
Drug:Ezetimibe 10mg;Drug:Ezetimibe 5
mgCompleted
Hypercholesterolemia
United States 2007-07-01
EzetrolPost-Marketing Study
Drug:simvastatin;Drug:Ezetimibe
Completed Hyperlipidemia Phase 4 2006-07-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
EfficacyofEzetimibe/Simvastatin 10/20mg andMK0524A(1-2g/Day) inMixedHyperlipidemiaand Twoor MoreRiskFactors
Drug:ezetimibe/simvastatin 10/20 mg +
placebo;Drug:ezetimibe/simvastatin
10/20 mg +MK0524A
WithdrawnCardiovascular
Diseases;Hyperlipidemia
Phase 4 2009-11-01
LeftVentricularHypertrophyReduction WithStatins inHypertensivesPatients(MK0653A-168)
Drug:valsartan;Drug:pravastatin;Drug:simvastatin;Drug:ezetim
ibe (+) simvastatin
Terminated Hypertension Phase 3 2008-01-01
VytorinonCarotidIntima-mediaThicknessandOverallRigidity
Drug:ezetimibe (+)simvastatin;Drug:simvastatin;Drug:pravas
tatin
CompletedCardiovascular
DiseasesPhase 4 2005-04-01
ObservationalStudy ofApproaches toLipid-LoweringTherapyin RussianPatientsWithCoronaryHeartDisease<>(StudyP05464)
Drug:Ezetimibe;Drug:Statin
CompletedCoronary Heart
Disease;Hypercholesterolemia
2008-01-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
RetrospectiveSurveyEvaluating theEffectiveness andSafety ofDualInhibitionLipid-loweringin theTreatment ofDyslipidemia(StudyP05171)(COMPLETED)
Drug:Ezetimibe 10mg plus statin orezetimibe 10 mgplus fenofibrate
Completed Dyslipidemia 2007-05-01
HypolipemicTreatment in AcuteCoronarySyndrome (ACS):AntithromboticEffects
Drug:simvastatin;Drug:ezetimibe;Drug:pl
acebo
Unknownstatus
Acute CoronarySyndrome
Poland 2008-06-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
A 52-weekPost-marketing,ObservationalStudy toConfirmthe SafetyandEfficacyof ZetiaAlone orinCombination WithOtherLipid-loweringDrugs inJapaneseSubjectsWithHypercholesterolemia(StudyP05245)
Drug:Ezetimibe;Drug:Ezetimibe + other
lipid-loweringmedication(s)
Completed
Hypercholesterolemia;Familial
Hypercholesterolemia;Homozygous Sitosterolemia
2007-06-01
Evaluation of theLDL-CLoweringEffects ofEzetimibeAchievedin Co-administrationTherapyWithStatins inanIndonesianPopulation (StudyP04276)(COMPLETED)
Drug:ezetimibe;Drug:statin
CompletedHypercholesterol
emia2006-01-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Evaluation of theSafety,Tolerability andEfficacyofEzetimibeon aSelectPopulation ofFilipinosWithHypercholesterolemia(StudyP04748)(COMPLETED)
Drug:Ezetimibe Completed
PrimaryHypercholesterolemia;Homozygo
us FamilialHypercholesterol
emia
2006-03-01
A 12-weekPost-marketing,ObservationalStudy toConfirmthe SafetyandEfficacyof ZetiaAlone orinCombination WithOtherLipid-loweringDrugs inJapaneseSubjectsWithHypercholesterolemia(StudyP05244)
Drug:Ezetimibe;Drug:Ezetimibe + other
lipid-loweringmedication(s)
Completed
Hypercholesterolemia;Familial
Hypercholesterolemia;Homozygous Sitosterolemia
2007-06-01
EzetimibeReverseCholesterolTransport(RCT)PilotStudy
Drug:ezetimibe;Drug:Placebo
CompletedHypercholesterol
emiaPhase 4 United States 2008-06-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
EzetimibeandStatins onPostprandialLipemiain Type 2Diabetes
Drug:ezetimibetablets;Drug:simvast
atintablets;Drug:placebo
CompletedPostprandial
Lipemia;Type 2Diabetes
Phase 4 Italy 2008-06-01
Effectiveness ofIntensiveLipidModificationMedication inPreventing theProgression ofPeripheral ArterialDisease(TheELIMITStudy)
Drug:Ezetimibe;Drug:Niaspan;Drug:Statintherapy;Behavioral:S
tandardcare;Drug:Aspirin;Drug:Clopidogrel;Drug:
PlaceboNiaspan;Drug:Placeb
oEzetimibe;Procedure
:Percutaneoustransluminal
angioplasty (PTA)
CompletedPeripheral
Arterial DiseasePhase 4 United States 2004-04-01
AMultiple-DosePharmacokineticInteraction StudyBetweenABT-335,Atorvastatin andEzetimibe
Drug:ABT-335;Drug:Atorvastati
n;Drug:EzetimibeCompleted
Pharmacokinetics
Phase 1 United States 2008-04-01
RiskReduction inCoronaryHeartDisease
Behavioral:smokingcessation;Drug:beta
blocker, diuretics,ACEI,
ARB,;Drug:statins,ezetimibe;Behavioral:training;Biological:in
fluenzavaccine;Drug:metfor
min, glimepiride,insulin;Behavioral:we
ight reduction
RecruitingCoronary Heart
DiseaseNorway 2007-09-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
LDL-CholesterolLoweringEffect ofKB2115as Addon toEzetimibe
Drug:Ezetimibe andplacebo;Drug:Eprotirome and ezetimibe
CompletedHypercholesterol
emiaPhase 2 Sweden 2008-04-01
INdiansFollowedforINtensiveLipidLoweringTreatment and ItssafetY
Drug:ezetimibe;Drug:Comparator:
Simvastatin 20, 40and 80
mg;Drug:Comparator:
Atorvastatin;Drug:Comparator:
Rosuvastatin
TerminatedHypercholesterol
emiaPhase 3 Canada 2007-08-01
BeginWith TheRightPatientsWithDual-InhibitionActionTherapyThroughVytorinfor NewlyDiagnosedDyslipidemiaPatients(0653A-172)(COMPLETED)
Drug:ezetimibe (+)simvastatin
CompletedHypercholesterol
emiaPhase 4 2007-08-01
CoadministrationofEzetimibeandAtorvastatin inPatientsWithPrimaryHypercholesterolemia(P05456)
Drug:Ezetimibe;Drug:atorvastatin
CompletedHypercholesterol
emiaPhase 3 2007-12-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Evaluation ofPotentialfor DrugInteractionBetweenSCH58235(Ezetimibe) andPitavastatin (StudyP03962)(COMPLETED)
Drug:SCH58235;Drug:pitavast
atinCompleted
Hypercholesterolemia
Phase 1 2004-03-01
EzetimibePlusSimvastatin VersusSimvastatin inUntreatedSubjectsWithHighCholesterol(P03435)
Drug:Ezetimibe +Simvastatin;Drug:Si
mvastatinCompleted
Hypercholesterolaemia;Atheroscle
rosisPhase 4 2003-09-01
EzetimibePlusAtorvastatin VersusAtorvastatin inUntreatedSubjectsWithHighCholesterol(P03434)
Drug:Ezetimibe +Atorvastatin;Drug:At
orvastatinCompleted
Hypercholesterolemia;Atheroscler
osisPhase 4 2003-09-01
CoadministrationofEzetimibeandSimvastatin inPatientsWithPrimaryHypercholesterolemia(P05457)
Drug:Ezetimibe;Drug:Simvastatin
CompletedHypercholesterol
emiaPhase 3 2007-12-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Comparethe Safety& EfficacyofRosuvastatin 40mginCombination WithEzetimibe10mg
Drug:Rosuvastatin;Drug:Ezetimibe
Completed
Hypercholesterolemia;Coronary
HeartDisease;Atherosc
lerosis
Phase 3 2004-06-01
MDEzetimibeCyclosporineInteraction (0653-057)
Drug:ezetimibe;Drug:Comparator:cyclosporine
Completed Cholesterol Phase 1 2003-11-01
RandomizedParallelGroupTrial OfTheEfficacyAndSafety OfEzetimibeWith AStatinVersusStatinDoseDoublingInPatientsWithPersistentPrimaryHypercholesterolemia(0653-152)(COMPLETED)
Drug:ezetimibe;Drug:statins
CompletedHypercholesterol
emiaPhase 4 2005-05-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Study ToAssessTheEfficacyOf ACholesterolLoweringDrug OnTop OfStatins InPatientsAfterMyocardialInfarction(MI)(0653A-150)
Drug:Ezetimibe;Drug:simvastatin
CompletedCardiovascular
DisorderPhase 4 2005-02-01
Effect OfEzetimibeCoadministrationWithSimvastatin In AMiddleEasternPopulation: AProspective,Multicentre,Randomized,Double-Blind,Placebo-Controlled Trial(0653-151)
Drug:ezetimibe;Drug:simvastatin;Drug:Pla
cebo (Unspecified)Completed
Hypercholesterolemia
Phase 4 2003-09-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Comparison ofEzetimibeAdded toOngoingStatinTherapyVersusDoublingthe Doseof Statinin theTreatment ofHypercholesterolemia(P04355)
Drug:Ezetimibe +Statin (simvastatin,
atorvastatin, orpravastatin);Drug:Do
uble Statin(simvastatin,
atorvastatin, orpravastatin)
CompletedHypercholesterol
emiaPhase 4 2005-12-01
AResearchStudy toEvaluateMK0653(Ezetimibe) andSimvastatin, GivenTogetherandAlone, onIntestinalAbsorption ofCholesterol (0653-050)(COMPLETED)
Drug:ezetimibe;Drug:Comparator:
Placebo(unspecified);Drug:si
mvastatin
Completed Cholesterol Phase 3 2003-07-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
OpenLabelStudyEvaluating The UseOfCombinationTherapyOfEzetimibeAndStatins InPatientsWithDyslipidemia InColombia(0653-141)(COMPLETED)
Drug:ezetimibe CompletedLipid Metabolism
DisorderPhase 4 2004-09-01
VytorinAsStrategyToReduceDislipidemia InAdults(0653A-148)
Drug:ezetimibe (+)simvastatin
Completed Hyperlipidemia Phase 3 2005-11-01
EzetimibePlusAtorvastatin VersusAtorvastatin AloneinSubjectsWithPrimaryHypercholesterolemia(StudyP03406)
Drug:Ezetimibe;Drug:Placebo
CompletedHypercholesterolemia;Atheroscler
osisPhase 3 2004-01-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Effect ofEzetimibePlusSimvastatin onFlow-MediatedBrachialArteryVasoactivity inSubjectsWithPrimaryHypercholesterolemia(StudyP03336)
Drug:Ezetimibe +Simvastatin;Drug:Simvastatin;Drug:Plac
ebo
TerminatedHypercholesterolemia;Atheroscler
osisPhase 3 2003-10-01
SwitchingtoRosuvastatin VersusAddingEzetimibetoAtorvastatin VersusDoublingthe DoseofAtorvastatin inPatientsWithHypercholesterolemia andRiskFactors(P03708)
Drug:Rosuvastatin;Drug:Ezetimibe +
Atorvastatin;Drug:Double Atorvastatin
Terminated
Hypercholesterolemia;Atheroscler
osis;CoronaryArtery Disease
Phase 4 2004-09-01
Comparison of Co-administration ofEzetimibePlusSimvastatin VersusSimvastatin AloneinPrimaryHypercholesterolemia(P03476)
Drug:Ezetimibe;Drug:Placebo
Completed
Atherosclerosis;Hypercholesterole
mia;CoronaryHeart Disease
Phase 4 2003-04-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
Assessment ofPotentialInteractionBetweenEzetimibeandRosuvastatin inHealthySubjectsWithHighCholesterol(P03317)
Drug:Ezetimibe +Rosuvastatin;Drug:Rosuvastatin;Drug:Placebo;Drug:Ezetimibe
CompletedHypercholesterolemia;Atheroscler
osisPhase 1 2003-03-01
EzetimibePlusSimvastatin VersusSimvastatin inPatientsWithHypercholesterolemia andCoronaryRiskFactors(P03405)
Drug:Ezetimibe;Drug:Placebo
TerminatedHypercholesterolemia;Atheroscler
osisPhase 4 2004-01-01
Comparison ofEzetimibePlusSimvastatin VersusEzetimibeorSimvastatin AloneinSubjectsWithPrimaryHypercholesterolemia(StudyP03757)(COMPLETED)
Drug:Ezetimibe +Simvastatin;Drug:Si
mvastatin;Drug:Ezetimibe
CompletedHypercholesterol
emiaPhase 3 2004-06-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
EzetimibePlusAtorvastatin VersusAtorvastatin inUntreatedSubjectsWithPrimaryHypercholesterolemia andCoronaryHeartDisease(P03396)
Drug:Ezetimibe +Atorvastatin;Drug:At
orvastatinCompleted
Hypercholesterolemia;Atheroscler
osis;CoronaryArtery Disease
Phase 3 2003-05-01
EzetimibePlusSimvastatin VersusSimvastatin AloneinAfrican-AmericanSubjectsWithPrimaryHypercholesterolemia(P03377)
Drug:Ezetimibe +Simvastatin;Drug:Si
mvastatinCompleted
Hypercholesterolemia;Atheroscler
osisPhase 4 2003-10-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
SafetyandEfficacyStudyComparing ABT-335CoadministeredWithAtorvastatin andEzetimibetoAtorvastatinCoadministeredWithEzetimibeinSubjectsWithMultipleAbnormalLipid (Fat)Levels inthe Blood
Drug:ABT-335;Drug:placebo;Drug:atorvastatin;Drug
:ezetimibe
Completed
Dyslipidemias;Coronary Heart
Disease;Combined (Atherogenic)
Dyslipidemia;Mixed Dyslipidemia
Phase 3 United States 2008-02-01
TheInfluenceofEzetimibeonGallbladderFunction
Drug:ezetimibe;Drug:Placebo
WithdrawnChronic
AcalculousCholecystitis
United States 2009-08-01
PharmacokineticDrugInteractionBetweenEzetimibeandTacrolimus AfterSingleDoseAdministration inHealthySubjects
Drug:1 tabletEzetrol(R)
(ezetimibe), MSDSharp & Dohme
GmbH,Germany;Drug:1
capsule Prograf(R)(tacrolimus), Astellas
Pharma GmbH,Germany;Drug:1
tablet Ezetrol(R) + 1capsules Prograf(R)
Completed
Pharmacokinetics;Drug
Interactions;Hypercholesterolemia;Immunosuppre
ssion
Phase 1 Germany 2007-09-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
PharmacokineticDrugInteractionBetweenEzetimibeandSirolimusAfterSingleDoseAdministration inHealthySubjects
Drug:1 tabletEzetrol(R)
(ezetimibe), MSDSharp & Dohme
GmbH,Germany;Drug:1
tablet Rapamune(R)(sirolimus), Wyeth
Pharma,Germany;Drug:1
tablet Ezetrol(R) + 1tablet Rapamune(R)
Completed
Pharmacokinetics;Drug
Interactions;Hypercholesterolemia;Immunosuppre
ssion
Phase 1 Germany 2007-04-01
ComprehensiveMagneticResonance ofPeripheral ArterialDisease
Drug:Simvastatin;Drug:Ezetimibe;Drug:Simvastatin/Ezetimibe
CompletedPeripheral Artery
DiseaseUnited States 2006-01-01
ARandomized,Double-BlindedStudy ofSimvastatin 20mg/DayVersusVytorin10/20 inSubjectsWithLipidProfilesNotMeetingCurrentNCEPGuidelines,Followinga Low-Carbohydrate Diet
Drug:simvastatin 20mg/ezetimibe
Completed HyperlipidemiaPhase
2/Phase3
2006-04-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
VascularEffects ofEzetimibe/Simvastatin andSimvastatin onAtherosclerosis
Drug:Simvastatin(Zocor);Drug:10mg/
10mg ofEzetimibe/Simvastati
n (Vytorin)
Completed Atherosclerosis Phase 4 Taiwan 2007-09-01
EvaluateLowDoses ofAEGR-733 onHepaticFatAccumulation byMRS
Drug:AEGR-733;Drug:placebo;Dr
ug:AEGR-733;Drug:AEGR-733;Drug:AEGR-
733;Drug:AEGR-733and
atorvastatin;Drug:AEGR-733 and
fenofibrate;Drug:AEGR-733 and
ezetimibe
Completed Hyperlipidemia Phase 2 United States 2007-10-01
Effect ofEzetimibePlusSimvastatin VersusSimvastatin AloneonAtherosclerosis intheCarotidArtery(ENHANCE)(P02578)
Drug:ezetimibe (plussimvastatin);Drug:pl
acebo (plussimvastatin)
Completed
Atherosclerosis;Hypercholesterolemia;Hyperlipopr
oteinemia Type II
Phase 3 2002-06-01
StudyEvaluating theEfficacyandSafety ofSimvastatin AloneCompared WithSimvastatin PlusEzetimibein Type 2DiabeticPatients(0653-021)(COMPLETED)
Drug:MK0653,ezetimibe / Duration
of Treatment: 30Weeks;Drug:Comparator : ezetimibe (+)
simvastatin /Duration of
Treatment: 30Weeks
CompletedDiabetes
Mellitus, Type 2Phase 3 2001-12-01
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
A StudyComparingEzetimibePlusSimvastatin VersusSimvastatin AloneinPatientsat Risk forHeartDisease(0653-023)(COMPLETED)
Drug:MK0653,ezetimibe / Duration
of Treatment: 27Weeks;Drug:MK0733
, simvastatin /Duration of
Treatment: 27Weeks;Drug:Compar
ator: simvastatin /Duration of
Treatment: 27Weeks
CompletedCoronaryDisease
Phase 3 2002-01-01
TheClinicalStudy ofPitavastatinTreatment forGroup ofMild toModerateAlzheimer's Disease
Drug:Pitavastatin;Drug:cholesterol-
lowering medicineother than
statin(e.g.,Ezetimibe,Colestimide)
TerminatedAlzheimer
Disease;Hypercholesterolemia
Japan 2007-11-01
Eze/Simva SwitchStudy inDiabetics(0653A-807)
Drug:MK0653A,ezetimibe (+)simvastatin /Duration of
Treatment: 6Weeks;Drug:Compar
ator: atorvastatin /Duration of
Treatment: 6 Weeks
CompletedDiabetes
Mellitus, Type 2Phase 3 2005-01-19
2017/11/21 ezetimibe Drug Report
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注册题目 干预措施 招募状态 研究疾病 研究阶段 国家 开始时间
A Studyto AssesstheCholesterolLoweringEffect ofEzetimibe/SimvastatinCombination TabletCompared toAnotherCholesterolLoweringDrug inElderlyPatientsWithHighCholesterol at HighorModerately HighRisk forCoronaryHeartDisease(0653A-128)
Drug:Atorvastatin 10mg;Drug:Ezetimibe10 mg/simvastatin
20mg;Drug:Atorvastati
n 20mg;Drug:Ezetimibe10 mg/simvastatin
40mg;Drug:Atorvastati
n 40 mg
CompletedHypercholesterol
emiaPhase 3 2007-11-01
12-weekOpen-label,Phase IIIbComparing EfficacyandSafety ofRosuvastatin(CRESTOR™) inCombination WithEzetimibe
Drug:Rosuvastatin(Crestor);Drug:Ezeti
mibe;Drug:Simvastatin
Completed
Hypercholesterolemia;Coronary
HeartDisease;Atherosc
lerosis
Phase 3
UnitedStates;Argentina;Brazil;Chile;Colombia;Lithuania;Netherlands;Peru;
Venezuela
2007-08-01