NCT00300339已完成2 期
Double-Blind, Double-Dummy, Randomized, Parallel Group Trial of SL650472 (Three Dose Regimens Versus Placebo and Cilostazol), for 24-Week Improvement of Walking Distance in Patients With Stage II Peripheral Arterial Disease Who Benefit From Optimal Prevention Strategy Including Clopidogrel
适应症
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
- 599
- 试验地点
- 9
- 主要终点
- Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline
研究概览
简要总结
To investigate in patients suffering from intermittent claudication due to Fontaine stage II PAD whether a 24-week treatment by SL650472 OD on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of SL650472 to placebo, and to calibrate 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
- •1. Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis origin (symptoms present for 6 months or longer and not significantly changed within the past 3 months);
- •2. ICD of 30 to 200 m at screening constant workload treadmill test
- •3. Doppler-measured pre-treadmill ABI of 0.90 or lower after 10 minutes of rest or, for patients with an ABI of greater than 1.3 (non-compressible arteries), a Toe-Brachial Index (TBI) of less than 0.7.
排除标准
- •1. Age below 40 years and/or onset of symptoms of PAD before the age of 40 years;
- •2. Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome);
- •3. Limb-threatening (grades III and IV) chronic limb ischemia, manifested by ischemic rest pain, ulceration, or gangrene.
- •4. Patients with a history of malignant or proliferate breast disease.
结局指标
主要结局
Primary: percent change in initial claudication distance (ICD) measured at the 24-week test, compared with that at baseline
次要结局
- Success, defined as an improvement of > 50% in ICD at the 24-week test compared with that at baseline
- Percent change in absolute claudication distance (ACD) at the 24-week test, compared with that at baseline,
- Functional status / quality of life (QoL) using WIQ and MOS SF-36 questionnaires,
- Hemodynamic measurement post treadmill test (ABI/TB).
研究者
研究点 (9)
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