NCT00443287已完成2 期
A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of HMR1766 Assessing the Efficacy and Safety of 3 Doses of HMR1766 Versus Placebo With Cilostazol as a Calibrator, Administered for 26 Weeks in Patients With Peripheral Arterial Disease (PAD) Fontaine Stage II
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 553
- 试验地点
- 1
- 主要终点
- Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline
研究概览
简要总结
The primary objective is to investigate in patients suffering from intermittent claudication due to Fontaine stage II Peripheral Arterial Disease (PAD) whether a 26-week treatment by HMR1766 on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of HMR1766 to placebo, and calibrating such effect versus cilostazol.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis etiology (symptoms present for 6 months or longer and not significantly changed within the past 3 months)
- •Initial claudication distance of 30 to 250 meters at screening constant workload treadmill test
- •Confirmation of underlying Peripheral Arterial Disease (PAD) at screening
- •Confirmation of symptom stability at randomization based on constant workload treadmill test performance
- •The patient must have optimal cardiovascular risk prevention and appropriate management of PAD, including clopidogrel at the dose of 75mg per day, during the study period
排除标准
- •Patient participated in investigational clinical trials in the last month prior to screening
- •Pregnant or breast-feeding woman or woman without documented double birth control measures for at least 3 months prior to randomization
- •Symptoms of PAD before the age of 40 years
- •Recent initiations or discontinuation of treatment by vasoactive agents (e.g., pentoxifylline, berprost sodium, papverine, isoxsuprine, nylidrin, cyclandelate, and niacin derivatives). Patients treated by cilostazol within 3 months prior to screening will also be excluded
- •Recent lower-extremity surgical or endovascular arterial reconstructions or sympathectomy, or recent deep venous thrombosis
- •Recent occurrence of at least one of the following: acute myocardial infarction, unstable angina, coronary artery bypass graft, percutaenous coronary intervention, transient ischemic attack or stroke
- •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
1
Placebo Comparator
干预措施: placebo (Drug)
2
Experimental
dose level 1
干预措施: ataciguat (HMR1766) (Drug)
3
Experimental
dose level 2
干预措施: ataciguat (HMR1766) (Drug)
4
Experimental
dose level 3
干预措施: ataciguat (HMR1766) (Drug)
5
Active Comparator
干预措施: cilostazol (Drug)
结局指标
主要结局
Primary efficacy endpoint: percent change in initial claudication distance (ICD) measured at the 26-week treadmill test, compared with ICD measured at baseline
时间窗: 26 weeks
次要结局
- Secondary efficacy endpoint: percent change in the absolute claudication distance(26 weeks)
- Safety endpoints: adverse events(study period)
研究者
研究点 (1)
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