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肺動脈性肺高血圧症(PAH)に対するリオシグアトの安全性に関する前向き非介入多施設共同市販後研究
基本情報
- NCT ID
- NCT02428985
- ステータス
- 完了
- 試験のフェーズ
- -
- 試験タイプ
- 観察
- 目標被験者数
- 882
- 治験依頼者名
- Bayer
概要
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.
対象疾患
Hypertension, Pulmonary
介入
Riociguat (ADEMPAS, BAY63-2521)(DRUG)
依頼者(Sponsor)
バイエル薬品株式会社(INDUSTRY)