Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 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
- 237
- 试验地点
- 2
- 主要终点
- Number of Participants With Death
研究概览
简要总结
Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1
排除标准
- •Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial
研究组 & 干预措施
Arm 1
干预措施: Riociguat (Adempas, BAY63-2521) (Drug)
结局指标
主要结局
Number of Participants With Death
时间窗: From baseline to end of safety follow-up visit, up to 10 years (1 month more than End of study visit)
Analyses of deaths were based on the assessment of causal relationship to study medication. The safety follow-up visit was to be performed 30 days after the last dose of riociguat.
Number of Participants With Treatment-emergent Adverse Events (TEAE)
时间窗: From administration of first dose of study medication up to 2 days after end of treatment with study medication, up to 10 years
Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.
次要结局
- Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Clinical Chemistry(From baseline to Termination visit, up to 10 years)
- Percentage of Participants With Treatment-emergent High Laboratory Abnormalities in Hematology and Coagulation(From baseline to Termination visit, up to 10 years)
- Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation(From baseline to Termination visit, up to 10 years)
- Change From Baseline of Hemoglobin in Hematology and Coagulation(From baseline to Termination visit, up to 10 years)
- Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Clinical Chemistry(From baseline to Termination visit, up to 10 years)
- Change From Baseline of Urate in Clinical Chemistry(From baseline to Termination visit, up to 10 years)