NCT00644605已完成3 期
A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2002年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test).
研究概览
简要总结
To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day [TID]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m.
排除标准
- •Subjects with congenital heart disease, pulmonary hypertension due to thromboembolism, HIV, chronic obstructive airway disease, congestive heart failure or schistosomiasis; subjects with significant (ie > 2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation; and acutely decompensated heart failure within the previous 30 days; subjects with pulmonary hypertension secondary to any other etiology other than those specified in the inclusion criteria.
研究组 & 干预措施
Arm 2
Active Comparator
干预措施: sildenafil (Drug)
Arm 3
Active Comparator
干预措施: sildenafil (Drug)
Arm 1
Active Comparator
干预措施: sildenafil (Drug)
Arm 4
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test).
时间窗: Week 12
次要结局
- Change from baseline in mean pulmonary arterial pressure(Week 12)
- Time from randomisation to the first occurrence of clinical worsening (death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy)(Week 0 to 12)
- Change from baseline in the BORG dyspnoea score(Week 12)
- Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class(Week 12)
- Change from baseline in the 8 dimensions of SF-36 (Physical functioning, Role functioning, Bodily pain, General health, Vitality, Social functioning, Mental health and Reported health transition)(Week 4 and Week 12)
- Change from baseline at Weeks 4 and 12 in the 5 dimensions of ED5Q (Mobility, Self care, Usual Activities, Pain/Discomfort and Anxiety/Depression)(Week 4 and Week 12)
- Patient overall preference assessment(Week 12)
- Change in Chronic Use of Background Therapy for Pulmonary Arterial Hypertension(throughout the study)
- Change from baseline in hemodynamic parameters(Week 12)
研究者
研究点 (1)
Loading locations...
相似试验
终止
4 期
To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.Pulmonary Arterial HypertensionNCT00430716Pfizer's Upjohn has merged with Mylan to form Viatris Inc.130
已完成
3 期
BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.Erectile DysfunctionNCT00668057Bayer624
已完成
4 期
A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile DysfunctionSpinal Cord TraumaInjuries, Spinal CordImpotenceErectile DysfunctionSpinal Cord InjuryNCT00654082Pfizer's Upjohn has merged with Mylan to form Viatris Inc.88
Unknown
3 期
A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different EtiologiesErectile DysfunctionNCT01321489Laboratório Teuto Brasileiro S/A78
已完成
4 期
A Study Evaluating the Efficacy and Safety of Sildenafil in Patients With Erectile Dysfunction Receiving HemodialysisErectile DisfunctionHemodialysisNCT00654017Pfizer's Upjohn has merged with Mylan to form Viatris Inc.100