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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)