NCT00454207已完成3 期
A Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial Hypertension
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 44 人开始时间: 2007年4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
- 44
- 试验地点
- 1
- 主要终点
- Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
研究概览
简要总结
To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 16 and over, and classified as having pulmonary arterial hypertension
- •Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest
- •Subjects whose baseline 6-Minute Walk test distance is >100 m and <450 m
排除标准
- •Significant Hepatic and/or renal disorder
- •Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)
- •Subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole
研究组 & 干预措施
sildenafil citrate (UK-92,480)
Experimental
sildenafil citrate 20 mg TID
干预措施: sildenafil citrate (UK-92,480) (Drug)
结局指标
主要结局
Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I
时间窗: Baseline, Week 12
Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline
Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I
时间窗: Baseline, Week 12
Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.
Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I
时间窗: Baseline, Week 12
Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.
Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I
时间窗: Baseline, week 12
Change：Cardiac output at Week 12 minus cardiac output at baseline
次要结局
- Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I(Baseline, Week 8)
- Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I(baseline, Week 12)
- Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I(baseline, Week 12)
- Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II(Baseline, Week 12)
- The Average Plasma Trough Concentration (Ctrough) of Sildenafil(Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing)
- Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 8, Week 12)
- Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 4, Week 8, Week 12)
- Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II(Baseline, Week 12)
- Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)(Baseline up to 1.3 years)
- Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I(Baseline, Week 12)
- Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II(Baseline, Week 12)
- Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320(Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing)
- Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320(Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing)
- The Average Plasma Concentration (Css,av) of Sildenafil at Steady State(Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing)
- Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II(Baseline, Week 12)
- The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320(Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing)
研究者
研究点 (1)
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