NCT00549302已完成3 期
An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
Study to determine the long term safety of tadalafil in patients with increased blood pressure in the blood vessel that carries blood from the right heart to the lungs and to see if it will keep the disease from getting worse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have participated and discontinued in the previous PAH placebo controlled study due to clinical worsening on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
- •Must have completed Week 16 of the previous PAH study and had either no clinical worsening or became clinically worse at the Week 16 visit on placebo or tadalafil 2.5 mg, 10mg, or 20 mg
- •Females who have a negative urine pregnancy test and are willing to use 2 types of birth control
- •Be 12 years or older (country specific regulations apply) with parental approval
排除标准
- •Participated in the placebo controlled study and had clinical worsening on 40 mg tadalafil
- •Have left-sided heart disease
- •Have a musculoskeletal disorder that limits being able to get around
- •Nitrate use
- •Certain current systemic treatments
研究组 & 干预措施
20 mg tadalafil
Active Comparator
20 milligram (mg) tadalafil taken once a day
干预措施: tadalafil (Drug)
40 mg tadalafil
Active Comparator
40 mg tadalafil tablet taken once a day
干预措施: tadalafil (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Baseline (Double-Blind Period) up to Week 243 (End of Open-Label Period)
A summary of serious and all other non-serious AEs, which include adverse events reported for laboratory tests and vital signs, is located in the Reported Adverse Event module.
次要结局
- 6-Minute Walk Distance (6MWD) at Baseline and Weeks 16, 28, 40 and 52(Baseline and Weeks 16, 28, 40 and 52)
- Borg Dyspnea Assessment at Baseline and Weeks 16, 28, 40 and 52(Baseline and Weeks 16, 28, 40 and 52)
- Probability of No Pulmonary Arterial Hypertension (PAH) Deterioration at Weeks 16, 28, 40 and up to 52(Baseline and Weeks 16, 28, 40 and 52)
研究者
研究点 (1)
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