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Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

2016年6月23日 更新者：Sanofi

A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

  • To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
  • To evaluate the effect of alirocumab on other lipid parameters
  • To evaluate the safety and tolerability of alirocumab

研究概览

地位

完全的

条件

干预/治疗

详细说明

The maximum study duration was 115 weeks per participant, including a 3-week screening period, 104-week randomized treatment period and 8-week follow-up period.

研究类型

介入性

注册 (实际的)

720

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 丹麦
      • Esbjerg、丹麦、6700
        • Investigational Site Number 208913
      • Glostrup、丹麦、2600
        • Investigational Site Number 208914
      • Hellerup、丹麦、2900
        • Investigational Site Number 208905
      • Herlev、丹麦、2730
        • Investigational Site Number 208911
      • Hvidovre、丹麦、2650
        • Investigational Site Number 208907
      • København S、丹麦、2300
        • Investigational Site Number 208901
      • Køge、丹麦、4600
        • Investigational Site Number 208906
      • Roskilde、丹麦、4000
        • Investigational Site Number 208908
      • Silkeborg、丹麦、8600
        • Investigational Site Number 208903
  • 乌克兰
      • Kiev、乌克兰、02091
        • Investigational Site Number 804905
      • Uzhhorod、乌克兰、88009
        • Investigational Site Number 804902
  • 以色列
      • Holon、以色列、58100
        • Investigational Site Number 376908
      • Kfar Saba、以色列、44281
        • Investigational Site Number 376903
      • Ofakim、以色列、80300
        • Investigational Site Number 376906
      • Petach Tikva、以色列
        • Investigational Site Number 376902
      • Rehovot、以色列、76100
        • Investigational Site Number 376904
      • Safed、以色列、13100
        • Investigational Site Number 376907
      • Tel Aviv、以色列、64239
        • Investigational Site Number 376901
  • 俄罗斯联邦
      • Barnaul、俄罗斯联邦、656055
        • Investigational Site Number 643906
      • Kemerovo、俄罗斯联邦、650002
        • Investigational Site Number 643903
      • Moscow、俄罗斯联邦、111539
        • Investigational Site Number 643927
      • Moscow、俄罗斯联邦、111539
        • Investigational Site Number 643928
      • Moscow、俄罗斯联邦、115404
        • Investigational Site Number 643931
      • Moscow、俄罗斯联邦、119048
        • Investigational Site Number 643924
      • Moscow、俄罗斯联邦、121374
        • Investigational Site Number 643932
      • Moscow、俄罗斯联邦、121552
        • Investigational Site Number 643908
      • Moscow、俄罗斯联邦、129090
        • Investigational Site Number 643904
      • Orenburg、俄罗斯联邦、450000
        • Investigational Site Number 643911
      • Ryazan、俄罗斯联邦、390026
        • Investigational Site Number 643921
      • Saint-Petersburg、俄罗斯联邦、197110
        • Investigational Site Number 643925
      • Saint-Petersburg、俄罗斯联邦、198205
        • Investigational Site Number 643922
      • Saratov、俄罗斯联邦、410028
        • Investigational Site Number 643929
      • St-Petersburg、俄罗斯联邦、199106
        • Investigational Site Number 643914
  • 加拿大
      • Brampton、加拿大、L6T 3J1
        • Investigational Site Number 124902
      • Mirabel、加拿大、J7J 2K8
        • Investigational Site Number 124914
      • Montreal、加拿大、H1T 3Y7
        • Investigational Site Number 124903
      • Toronto、加拿大、M9V 4B4
        • Investigational Site Number 124918
  • 匈牙利
      • Budapest、匈牙利、1036
        • Investigational Site Number 348908
      • Budapest、匈牙利、1134
        • Investigational Site Number 348901
      • Budapest、匈牙利、1134
        • Investigational Site Number 348903
      • Debrecen、匈牙利、4032
        • Investigational Site Number 348905
      • Szekesfehervar、匈牙利、8000
        • Investigational Site Number 348906
  • 南非
      • Alberton、南非、1450
        • Investigational Site Number 710917
      • Bloemfontein、南非、9301
        • Investigational Site Number 710909
      • Bloemfontein、南非、9301
        • Investigational Site Number 710914
      • Cape Town、南非、7500
        • Investigational Site Number 710905
      • Cape Town、南非、7925
        • Investigational Site Number 710904
      • Middelburg、南非、1055
        • Investigational Site Number 710918
      • Pretoria、南非、0002
        • Investigational Site Number 710913
      • Somerset West、南非、7130
        • Investigational Site Number 710915
  • 大韩民国
      • Anyang-Si、大韩民国、431-070
        • Investigational Site Number 410908
      • Busan、大韩民国、602-715
        • Investigational Site Number 410920
      • Daegu、大韩民国、700-712
        • Investigational Site Number 410926
      • Gwangju、大韩民国、501-757
        • Investigational Site Number 410923
      • Seoul、大韩民国、110-744
        • Investigational Site Number 410909
      • Seoul、大韩民国、120-752
        • Investigational Site Number 410922
      • Seoul、大韩民国、135-710
        • Investigational Site Number 410921
      • Seoul、大韩民国、135-720
        • Investigational Site Number 410905
      • Seoul、大韩民国、137-701
        • Investigational Site Number 410901
      • Seoul、大韩民国、138-736
        • Investigational Site Number 410914
      • Seoul、大韩民国、156-707
        • Investigational Site Number 410924
      • Suwon、大韩民国、443-721
        • Investigational Site Number 410915
      • Uijeongbu、大韩民国、480-717
        • Investigational Site Number 410913
      • Wonju、大韩民国、220-701
        • Investigational Site Number 410927
  • 法国
      • Dijon、法国、21079
        • Investigational Site Number 250906
      • Montpellier Cedex 5、法国、34295
        • Investigational Site Number 250907
      • Nantes、法国、44093
        • Investigational Site Number 250903
      • Nimes、法国、30900
        • Investigational Site Number 250905
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35209
        • Investigational Site Number 840980
    • Arizona
      • Phoenix、Arizona、美国、85032
        • Investigational Site Number 840918
      • Tucson、Arizona、美国
        • Investigational Site Number 840925
    • California
      • Anaheim、California、美国、92801
        • Investigational Site Number 840959
      • Beverly Hills、California、美国、90211
        • Investigational Site Number 840301
      • Chino、California、美国、91710
        • Investigational Site Number 840933
      • Lincoln、California、美国、95648
        • Investigational Site Number 840991
      • Los Angeles、California、美国、90057
        • Investigational Site Number 840979
      • Palm Springs、California、美国、92262
        • Investigational Site Number 840952
      • Thousand Oaks、California、美国、91360
        • Investigational Site Number 840930
      • Vista、California、美国、92083
        • Investigational Site Number 840921
    • Florida
      • Boynton Beach、Florida、美国、33472
        • Investigational Site Number 840962
      • Bradenton、Florida、美国、34203
        • Investigational Site Number 840987
      • Clearwater、Florida、美国、33756
        • Investigational Site Number 840302
      • Jacksonville、Florida、美国、32223
        • Investigational Site Number 840935
      • Miami、Florida、美国、33126
        • Investigational Site Number 840903
      • Miami、Florida、美国
        • Investigational Site Number 840920
      • Ocala、Florida、美国、34471
        • Investigational Site Number 840943
      • Oveido、Florida、美国、32765
        • Investigational Site Number 840981
      • Port Orange、Florida、美国、32127
        • Investigational Site Number 840961
      • Sarasota、Florida、美国、34239
        • Investigational Site Number 840303
      • St. Petersburg、Florida、美国
        • Investigational Site Number 840986
      • St. Petersburg、Florida、美国
        • Investigational Site Number 840988
    • Idaho
      • Meridian、Idaho、美国、83646
        • Investigational Site Number 840995
    • Indiana
      • Evansville、Indiana、美国、47714
        • Investigational Site Number 840902
    • Kansas
      • Topeka、Kansas、美国、66606
        • Investigational Site Number 840960
    • Maryland
      • Oxon Hill、Maryland、美国、20745
        • Investigational Site Number 840940
    • Massachusetts
      • Fall River、Massachusetts、美国、02720
        • Investigational Site Number 840966
    • Missouri
      • Kansas City、Missouri、美国、64114
        • Investigational Site Number 840917
      • St. Louis、Missouri、美国、63131
        • Investigational Site Number 840998
    • Montana
      • Butte、Montana、美国、59701
        • Investigational Site Number 840946
    • Nebraska
      • Lincoln、Nebraska、美国、68510
        • Investigational Site Number 840914
    • New Mexico
      • Albuquerque、New Mexico、美国、87106
        • Investigational Site Number 840949
    • New York
      • New Windsor、New York、美国、12553
        • Investigational Site Number 840974
    • North Carolina
      • Greenville、North Carolina、美国、27834
        • Investigational Site Number 840955
      • Lexington、North Carolina、美国、27292
        • Investigational Site Number 840938
      • Smithfield、North Carolina、美国、27577
        • Investigational Site Number 840976
      • Winston-Salem、North Carolina、美国、27103
        • Investigational Site Number 840985
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • Investigational Site Number 840963
      • Lyndhust、Ohio、美国、44124
        • Investigational Site Number 840970
      • Marion、Ohio、美国、43302
        • Investigational Site Number 840906
      • Marion、Ohio、美国、43302
        • Investigational Site Number 840997
      • Perrysburg、Ohio、美国、43551
        • Investigational Site Number 840964
    • South Carolina
      • Charleston、South Carolina、美国、29412
        • Investigational Site Number 840913
      • Greer、South Carolina、美国、29651
        • Investigational Site Number 840912
      • Summerville、South Carolina、美国、29485
        • Investigational Site Number 840992
    • Tennessee
      • Bristol、Tennessee、美国、37620
        • Investigational Site Number 840932
      • Nashville、Tennessee、美国、37205
        • Investigational Site Number 840944
    • Texas
      • Fort Worth、Texas、美国、76104
        • Investigational Site Number 840994
      • Houston、Texas、美国、77070
        • Investigational Site Number 840973
      • Houston、Texas、美国、77074
        • Investigational Site Number 840939
      • Sugar Land、Texas、美国、77479
        • Investigational Site Number 840945
      • Tomball、Texas、美国、77375
        • Investigational Site Number 840971
    • Utah
      • Orem、Utah、美国、84058
        • Investigational Site Number 840982
    • Virginia
      • Norfolk、Virginia、美国、23502
        • Investigational Site Number 840931
      • Richmond、Virginia、美国、23227
        • Investigational Site Number 840984
    • Washington
      • Renton、Washington、美国、98055
        • Investigational Site Number 840928
      • Spokane、Washington、美国、99204
        • Investigational Site Number 840990

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria:

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria:

  • Age < 18 or legal age of adulthood, whichever was greater
  • Participants without established CHD or CHD risk equivalents
  • LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented cardiovascular disease
  • LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented CV disease
  • Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Alirocumab 75 /up to 150 mg Q2W
Alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
药品：Alirocumab
通过自我注射或由其他指定人员使用自动注射器在腹部、大腿或上臂外侧区域皮下注射 1 mL。
其他名称：
  • 普拉鲁特
  • REGN727/SAR236553
药品：Placebo (for ezetimibe)
One capsule once daily orally at approximately the same time of the day with or without food.
药品：Lipid Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
有源比较器：Ezetimibe 10 mg
Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks.
药品：依折麦布
每天一次，大约在一天中的同一时间口服一粒包覆胶囊的药片，有或没有食物。
药品：Lipid Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
药品：Placebo (for alirocumab)
1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis
大体时间：From Baseline to Week 52
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).
From Baseline to Week 52

次要结果测量

结果测量
措施说明
大体时间
第 24 周非高密度脂蛋白胆固醇（非 HDL-C）相对于基线的百分比变化 - ITT 分析
大体时间：从基线到第 52 周
MMRM 模型在第 24 周调整后的 LS 均值和标准误差，包括从第 4 周到第 52 周的所有可用基线后数据，无论治疗或治疗状态如何。
从基线到第 52 周
第 24 周时总胆固醇（总 C）相对于基线的百分比变化 - ITT 分析
大体时间：从基线到第 52 周
MMRM 模型在第 24 周调整后的 LS 均值和标准误差，包括从第 4 周到第 52 周的所有可用基线后数据，无论治疗或治疗状态如何。
从基线到第 52 周
第 12 周非 HDL-C 相对于基线的百分比变化 - ITT 分析
大体时间：从基线到第 52 周
MMRM 模型在第 12 周调整后的 LS 均值和标准误差，包括从第 4 周到第 52 周的所有可用的基线后数据，无论治疗或治疗状态如何。
从基线到第 52 周
第 12 周总 C 相对于基线的百分比变化 - ITT 分析
大体时间：从基线到第 52 周
MMRM 模型在第 12 周调整后的 LS 均值和标准误差，包括从第 4 周到第 52 周的所有可用的基线后数据，无论治疗或治疗状态如何。
从基线到第 52 周
第 24 周时 HDL-C 相对于基线的百分比变化 - ITT 分析
大体时间：从基线到第 52 周
MMRM 模型在第 24 周调整后的 LS 均值和标准误差，包括从第 4 周到第 52 周的所有可用基线后数据，无论治疗或治疗状态如何。
从基线到第 52 周
第 12 周时 HDL-C 相对于基线的百分比变化 - ITT 分析
大体时间：从基线到第 52 周
MMRM 模型在第 12 周调整后的 LS 均值和标准误差，包括从第 4 周到第 52 周的所有可用的基线后数据，无论治疗或治疗状态如何。
从基线到第 52 周
第 24 周脂蛋白 (a) 相对于基线的百分比变化 - ITT 分析
大体时间：从基线到第 52 周
第 24 周的调整均值和标准误差是通过多重插补方法获得的，随后是用于处理缺失数据的稳健回归模型。 从第 4 周到第 52 周的所有可用的基线后数据，无论是否接受治疗，都包括在插补模型中。
从基线到第 52 周
第 12 周 Apo A-1 相对于基线的百分比变化 - ITT 分析
大体时间：从基线到第 52 周
MMRM 模型在第 12 周调整后的 LS 均值和标准误差，包括从第 4 周到第 52 周的所有可用的基线后数据，无论治疗或治疗状态如何。
从基线到第 52 周
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
大体时间：From Baseline to Week 52
Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis
大体时间：From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
大体时间：From Baseline to Week 52
Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis
大体时间：From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
大体时间：From Baseline to Week 52
Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
大体时间：From Baseline to Week 52
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
From Baseline to Week 52
Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis
大体时间：From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
大体时间：From Baseline to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
From Baseline to Week 52
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
大体时间：From Baseline up to Week 52
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
From Baseline up to Week 52
Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis
大体时间：From Baseline to Week 52
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
大体时间：From Baseline to Week 52
Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.
From Baseline to Week 52
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
大体时间：Up to Week 52
Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were included in the imputation model.
Up to Week 52
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
大体时间：Up to Week 52
Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from week 4 to week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Up to Week 52
Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis
大体时间：From Baseline to Week 52
Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
From Baseline to Week 52

其他结果措施

结果测量
措施说明
大体时间
Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis
大体时间：From Baseline to Week 52
Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis
大体时间：From Baseline to Week 104
Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment.
From Baseline to Week 104
Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis
大体时间：From Baseline to Week 104
Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
From Baseline to Week 104

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sanofi

合作者

Regeneron Pharmaceuticals

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年8月1日

初级完成 (实际的)

2014年5月1日

研究完成 (实际的)

2015年7月1日

研究注册日期

首次提交

2012年7月16日

首先提交符合 QC 标准的

2012年7月16日

首次发布 (估计)

2012年7月18日

研究记录更新

最后更新发布 (估计)

2016年8月4日

上次提交的符合 QC 标准的更新

2016年6月23日

最后验证

2016年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • EFC11569
  • U1111-1121-4315 (其他标识符：UTN)
  • 2011-004130-34 (EudraCT编号)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Japan

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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