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 Symptomatic Pulmonary Arterial Hypertension (PAH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 445
- 试验地点
- 1
- 主要终点
- 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12
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 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).
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 symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)
- •Treatment naive patients and patients pre-treated with an Endothelin Antagonist or a Prostacyclinanalogue (except I.V.).
排除标准
- •All types of pulmonary hypertension except subtypes of Venice Group I specified in the inclusion criteria, severe COPD (chronic obstructive pulmonary disease), uncontrolled arterial hypertension, left heart failure.
研究组 & 干预措施
Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT
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 12 weeks
干预措施: Riociguat (Adempas, BAY63-2521) (Drug)
Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT
Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 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 12 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 12
时间窗: Baseline and week 12
6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.
次要结局
- Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12(Baseline and week 12)
- N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12(Baseline and week 12)
- World Health Organization (WHO) Functional Class - Change From Baseline to Week 12(Baseline and week 12)
- Percentage of Participants With Clinical Worsening(At week 12)
- Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12(Baseline and week 12)
- EQ-5D Utility Score - Change From Baseline to Week 12(Baseline and week 12)
- Borg CR 10 Scale - Change From Baseline to Week 12(Baseline and week 12)