CTRI/2016/07/007068已完成3 期
A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacyand Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Asiain High Cardiovascular Risk Patients With Hypercholesterolemia NotAdequately Controlled With Their Statin Therapy - Odyssey East
Sanofi Synthelabo India Private Limited0 个研究点目标入组 112 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin.
- •For details Including area please see the Protocol.
排除标准
- •Main Exclusion Criteria
- •E01. Patients without established CHD or CHD risk equivalents
- •E02. LDL-C 70 mg/dL (1.81 mmol/L) at the screening visit (Week -3) in
- •patients with history of documented CV disease
- •E03. LDL-C 100 mg/dL (2.59 mmol/L) at the screening visit (Week -3)
- •in patients without history of documented CV disease
- •NOTE â?? Cardiovascular disease (CVD) is defined as CHD, ischemic stroke or
- •peripheral arterial disease (PAD) as described in Section 7.1
- •E04. Change in statin dose or dose regimen from screening to
- •randomization
- •E05. Currently taking a statin other than atorvastatin, rosuvastatin or
- •simvastatin
- •E06. Atorvastatin, rosuvastatin or simvastatin is not taken daily or not
- •taken at a registered dose
- •E07. Daily doses above atorvastatin 80 mg, rosuvastatin 20 mg or
- •simvastatin 40 mg
- •E08. Use of cholesterol absorption inhibitor (ie, ezetimibe), omega-3 fatty
- •acid (at doses >=1000 mg daily), nicotinic acid, fibrates, bile
- •acid-binding sequestrant, or red yeast rice products in the past
- •4 weeks prior to screening visit (Week -3)
- •E09. Fasting serum triglycerides 400 mg/dL (4.52 mmol/L) at the screening period.
研究者
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