NCT02060487终止4 期
A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.80 个研究点 分布在 15 个国家目标入组 385 人开始时间: 2014年9月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 385
- 试验地点
- 80
- 主要终点
- Overall Survival
研究概览
简要总结
This is a blinded study in adult patients with PAH evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day [TID]). In addition, the relative effects on clinical worsening and 6-minute walking distance (6MWD) will be assessed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 18 <75 years of age with any of the following conditions:
- •Idiopathic Primary Pulmonary Arterial Hypertension (IPAH)
- •PAH secondary to connective tissue disease
- •PAH with surgical repair (at least 5 years previously) of atrial septal defect (ASD),ventricular septal defect (VSD), patent ductus arteriosus (PDA) and aorto-pulmonary window
- •PAH diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization
- •Functional Class II-IV; Baseline 6MWD ≥ 50 m.
排除标准
- •Significant (ie, >2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation
- •History of cardiac arrest, respiratory arrest, hemodynamic collapse, CPR, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation
- •History of pulmonary embolism; History of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (COPD) or scleroderma) with impairment of lung function
- •No prior long term treatment with PDE-5 inhibitors
- •Treatment with bosentan OR riociguat within 3 months of randomization
- •Current treatment with nitrates or nitric oxide
研究组 & 干预措施
Low dose
Experimental
干预措施: sildenafil citrate (Drug)
Medium dose
Experimental
干预措施: sildenafil citrate (Drug)
High dose
Experimental
干预措施: sildenafil citrate (Drug)
结局指标
主要结局
Overall Survival
时间窗: Day 1 of study treatment up to date of death (within a maximum duration of 2102 days)
In this outcome measure number of deaths during the study were reported.
次要结局
- Number of Participants With Clinical Worsening Events(Day 1 of study treatment up to date of clinical worsening event (within a maximum duration of 2080 days))
- Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 6(Baseline, Month 6)
- Change From Baseline in 6-Minute Walk Distance (6MWD) at Month 12(Baseline, Month 12)
研究者
研究点 (80)
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