Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,298
- 主要终点
- Number of participants with treatment emergent adverse events and adverse drug reactions
研究概览
简要总结
This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for inoperable CTEPH(Chronic thromboembolic pulmonary hypertension)/ persistent or recurrent CTEPH after surgical treatment. It is planned to include a total of 400 patients (valid for safety analysis). This study is performed as an all-case investigation. The treatment of Riociguat is performed based on the product label in Japan. The standard observation period is 12 months from the 1st treatment of Riociguat. Safety and effectiveness are evaluated at 4th and 12th month. In addition, the extension observation is carried out once a year for 7 years at the longest to collect information on safety and effectiveness as long as Riociguat treatment continues. When the treatment of Riociguat is terminated, observation of a patient ends. For each patient, the investigator records data as defined in the protocol at each evaluation point by using the Electronic Data Capture (EDC) system. The duration of the study is approximately 9 years from launch.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are treated with Riociguat for CTEPH
排除标准
- •Patients who are contraindicated based on the product label
研究组 & 干预措施
Group 1
Riociguat treatment group
干预措施: Riociguat (ADEMPAS, BAY63-2521) (Drug)
结局指标
主要结局
Number of participants with treatment emergent adverse events and adverse drug reactions
时间窗: up to 8 years
次要结局
- Change from baseline in 6MWD (6-Minute Walking Distance) after 4 and 12 months(baseline and 4 months, and 12 months)
- Change from baseline in Pulmonary Vascular Resistance (PVR) after 4 and 12 months(baseline and 4 months, and 12 months)
- Change from baseline in TRPG (Tricuspid Regurgitation Pressure Gradient) after 4 and 12 months(baseline and 4 months, and 12 months)
- Change from baseline in BNP/NT-pro BNP after 4 and 12 months(baseline and 4 months, and 12 months)
- Change from baseline in WHO (World Health Organization) functional class after 4 and 12 months(baseline and 4 months, and 12 months)
- Time to Clinical Worsening(up to 8 years)