TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
研究概览
简要总结
This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who were enrolled in and completed Study RIV-PH-402 (TRUST-1)
排除标准
- •Subjects who were unblinded for potential rescue therapy in Study RIV-PH-402 and were found to be allocated to the Remodulin treatment group were not eligible to participate in this study.
研究组 & 干预措施
Intravenous Treprostinil
Intravenous treprostinil was supplied as 1 mg/mL.
干预措施: Intravenous Treprostinil (Drug)
结局指标
主要结局
Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)
时间窗: The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
Effect of Long-term Remodulin Therapy on Subject Safety
时间窗: Baseline to Week 12
Safety was assessed by summarizing the number of subjects with at least 1 AE during the 12 weeks (or until premature termination).
Effect of Long-term Remodulin Therapy on the NYHA Functional Classification
时间窗: The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit
The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
次要结局
未报告次要终点