Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 882
- 试验地点
- 1
- 主要终点
- Number of participants with treatment emergent adverse events. Adverse events of special interest:Hypotension,Gastrointestinal disorder,Hemoptysis, pulmonary hemorrhage and Pulmonary congestion, pulmonary edema
研究概览
简要总结
The primary objective in this study is to collect post-marketing information on Riociguat safety.Thus, the information on adverse events (AEs) and adverse drug reactions (ADRs) that occur within the first 12 months and in the following 6 -year observation at most, after starting Riociguat treatment under the routine clinical practice will be collected.
The secondary objectives are collecting information on Riociguat effectiveness, such as 6-Minute Walking Distance (6MWD) Test. Since it is assumed that Riociguat is for long-term use, information on Pulmonary Arterial Hypertension (PAH) clinical worsening will also be surveyed once a year.
详细描述
This local, prospective, non-interventional, multi-center study includes patients treated with Riociguat for PAH. A total of 600 patients (valid for safety analysis) is planned to be included in 4 years. This study is performed as an "all-case investigation" therefore; all patients who receive Riociguat treatment for PAH need to be registered, in principle. The treatment should be performed based on the product label in Japan. The standard observation period will last for 12 months from starting Riociguat treatment. Safety and effectiveness will be evaluated at the 3rd and 12th month of treatment. In addition, the extension observation period will be carried out as long as Riociguat treatment continues or at most for more 6 years. The purpose is to collect information on safety and effectiveness, such as adverse events and clinical worsening of PAH, once a year. Combining the standard observation and the extension observation period the patient could be followed for at most 7 years. When Riociguat treatment is terminated, the observation of the patient ends. The investigator should record data for each patient, as defined in the protocol, using the Electronic Data Capture (EDC) system. The duration of the study is of approximately 8 years from PAH indication approval.
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 PAH
排除标准
- 未提供
研究组 & 干预措施
Riociguat
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. Adverse events of special interest:Hypotension,Gastrointestinal disorder,Hemoptysis, pulmonary hemorrhage and Pulmonary congestion, pulmonary edema
时间窗: Up to 7 years
Number of participants with adverse drug reaction
时间窗: Up to 7 years
次要结局
- Change from baseline in Pulmonary Vascular Resistance (PVR) after 3 and 12 months(Baseline and 3 months,Baseline and 12 months)
- Change in blood concentration from baseline in brain natriuretic peptide / N-terminal pro-brain natriuretic peptide (BPN/NT-pro BNP) after 3 and 12 months.(Baseline and 3 months,Baseline and 12 months)
- Change from baseline in 6-Minute Walking Distance at 3 months and 12 months(Baseline and 3 months,Baseline and 12 months)
- Change from baseline in tricuspid regurgitation pressure gradient (TRPG) after 3 and 12 months(Baseline and 3 months,Baseline and 12 months)
- Change from baseline in WHO functional class after 3 and 12 months(Baseline and 3 months,Baseline and 12 months)
- Time to Clinical Worsening(Up to 7 years)