NCT00718965终止3 期
A Double-blind, Randomized, 12-month, Placebo-controlled, Parallel Group, Fixed-dose Study to Evaluate the Efficacy and Safety of AVE5530 25mg/Day and AVE5530 50 mg/Day in Patients With Primary Hypercholesterolemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 826
- 试验地点
- 1
- 主要终点
- percent change from baseline in calculated LDL-C
研究概览
简要总结
The present study is aiming at assessing the efficacy and safety of AVE5530 (25mg and 50mg) in a double-blind comparison with placebo in the management of patients with primary hypercholesterolemia. The main objective is to evaluate the effects of AVE5530 on LDL-C level reduction as adjunct to a controlled diet. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.
详细描述
The study will include a 2-week pre-randomization placebo lead-in phase and a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy
排除标准
- •LDL-C levels > 250 mg/dL (6.48 mmol/L)
- •Triglycerides levels > 350mg/dL (3.95 mmol/L)
- •Conditions / situations such as:
- •presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels
- •Active liver disease
- •High estimated risk of Coronary Heart Disease
- •Recent history of congestive heart failure , of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease
- •Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody or Known to be Human Immunodeficient Virus (HIV) positive
- •Pregnant or breast-feeding women,
- •Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
25 mg/day AVE5530
Experimental
干预措施: AVE5530 (Drug)
50 mg/day AVE5530
Experimental
干预措施: AVE5530 (Drug)
结局指标
主要结局
percent change from baseline in calculated LDL-C
时间窗: at week 12
次要结局
- percent change from baseline in calculated LDL-C(at 6 months and 12 months)
- percent change from baseline in total cholesterol and Apo-B(at 12 weeks, 6 months and 12 months)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
Evaluation of Efficacy and Safety of AVE5530 Co-administered With Atorvastatin in Primary HypercholesterolemiaHypercholesterolemiaNCT00741715Sanofi1,736
终止
3 期
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing High Doses of Statins in Patients With Primary Severe HypercholesterolemiaHypercholesterolemiaNCT00766688Sanofi643
终止
3 期
Evaluation of Safety and Efficacy of AVE5530 as add-on to Ongoing Statins in Patients With Primary HypercholesterolemiaHypercholesterolemiaNCT00729027Sanofi1,015
已完成
2 期
Efficacy Study of AVI-4658 to Induce Dystrophin Expression in Selected Duchenne Muscular Dystrophy PatientsDuchenne Muscular DystrophyNCT01396239Sarepta Therapeutics, Inc.12
已完成
1 期
Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650Healthy SubjectsNCT00364039Avigen30