Long-term Extension, Multicentre, Multi-national 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 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
- 396
- 试验地点
- 3
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAE)
研究概览
简要总结
Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.
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 12 weeks of treatment in the double blind trial PATENT 1
排除标准
- •Patients who have an ongoing serious adverse event from PATENT 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 (BAY63-2521) (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAE)
时间窗: From administration of first dose of study medication in PATENT-2 up to 2 days after end of treatment with study medication, up to 10 years and 5 months.
Analyses of drug-related TEAEs were based on the assessment of causal relationship to study medication.
Number of Participant With Death
时间窗: From baseline to end of safety follow-up visit, up to 10 years and 6 months (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.
次要结局
- Percentage of Participants With Treatment-emergent Low Laboratory Abnormalities in Hematology and Coagulation(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 High Laboratory Abnormalities in Clinical Chemistry(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)