肺動脈性高血圧症（PAH）患者におけるマシテンタンとタダラフィルの単剤療法と対応する固定用量併用療法の有効性と安全性を比較する臨床試験

基本情報

NCT ID

NCT03904693

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

187

治験依頼者名

Actelion

概要

Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.

対象疾患

介入

依頼者（Sponsor）

実施施設 (26)