Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16
研究概览
简要总结
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
详细描述
Adverse event data will be covered in Adverse events section.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery.
排除标准
- •All types of pulmonary hypertension except subtypes 4.1 and 4.2 of the Venice Clinical Classification of Pulmonary Hypertension.
研究组 & 干预措施
Riociguat (Adempas, BAY63-2521)_individual dose titration
Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
干预措施: Riociguat (Adempas, BAY63-2521) (Drug)
Placebo
Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 16
时间窗: Baseline and week 16
6-minute walking distance (6MWD) is a measure for the objective evaluation of a participant's functional exercise capacity.
次要结局
- Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16(Baseline and week 16)
- Percentage of Participants With Clinical Worsening(At week 16)
- Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 16(Baseline and week 16)
- N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 16(Baseline and week 16)
- World Health Organization (WHO) Functional Class - Change From Baseline to Week 16(Baseline and week 16)
- Borg CR 10 Scale - Change From Baseline to Week 16(Baseline and week 16)
- EQ-5D Utility Score - Change From Baseline to Week 16(Baseline and week 16)