NCT00540436已完成2 期
Study AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A -<Classification: Exploratory and Confirmatory Clinical Trial>
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12
研究概览
简要总结
The primary objective of this study is to evaluate the effect of GSK1325760A on improvement in exercise capacity in subjects with pulmonary arterial hypertension (PAH).
The secondary objectives of this study are to evaluate administration of GSK1325760A on:
- The safety and tolerability
- Improvement of PAH
- The steady-state plasma pharmacokinetics of GSK1325760A
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GSK1325760A
Experimental
Single arm safety and efficacy
干预措施: GSK1325760A (Drug)
结局指标
主要结局
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12
时间窗: Baseline and Week 12
Mean change from baseline was calculated as the Week 12 value minus the baseline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes.
次要结局
- Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal(Baseline and Week 24/Withdrawal)
- Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24(Baseline and Weeks 12 and 24)
- Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24(Weeks 12 and 24)
- Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event(Week 24)
- Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24(Baseline and Weeks 12 and 24)
- Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24(Baseline and Weeks 12 and 24)
- Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24(Baseline and Weeks 12 and 24)
- Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24(Baseline and Weeks 12 and 24)
- Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24(Baseline and Weeks 12 and 24)
研究者
研究点 (1)
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