Etude préliminaire Sur l'efficacité Aigue du Sildenafil Sur le Temps de Marche Chez Les Patients Atteints d'AOMI de Stade II présentant Une Claudication artérielle
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 主要终点
- Walking duration on treadmill
研究概览
简要总结
Efffect of a single dose oral intake of sildenafil Or placebo on the walking capacity on treadmill of PAD patients with claudication
详细描述
Sildenafil 100mg or Placebo Oral intake 2 hours before the treadmill test Safety and security control throughout the period of drug efficacy (approx 4 hours) Evaluation of maximal walking distance for a constant load treadmill test (3.2 kml/h 10% slope)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient with peripheral arterial desease stade II
- •Patient with vascular claudication for at least 3 months
- •Patient able to perform a treadmill walking test with time to walk < 5min
排除标准
- •Patient suffering from ischemia
- •Previous angina or myocardial
- •Patient treated with nitrates drugs
- •Patient with severe renal insufficiency
- •Patient with severe hepatic insufficiency
- •Patient with hypotension
研究组 & 干预措施
Sildenafil
Single sildenafil oral intake (100 mg) approximately 2 hours before the treadmill test.
干预措施: Sildenafil 100mg single oral dose (Drug)
Placebo
Single placebo intake approximately 2 hours before the treadmill test.
干预措施: Placebo, Oral intake single dose (Drug)
结局指标
主要结局
Walking duration on treadmill
时间窗: 2 hours after treatment intake
Treadmill test with consttant load procedure 3.2 km/h H 10% slope up to 15 minutes followed by incremental load according tpo the Bruce protocole thereafter.
次要结局
未报告次要终点