Science and Research

Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension

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.

Study details
Study-ID: NCT03904693
Study-ID: NCT03904693
DZL Disease Area: PH
DZL Disease Area: PH
Study Type: Interventional
Study Type: Interventional
DZL Role: DZL on steering board, DZL recruiting center
DZL Role: DZL on steering board, DZL recruiting center
Funding: Externally - industry
Funding: Externally - industry
DZL Participating Sites: TLRC, UGMLC
DZL Participating Sites: TLRC, UGMLC
Start Date: 01.07.2019
Completion Date: 30.09.2024
Status: Closed
Status: Closed
DZL on steering board, DZL recruiting center
Link to Study


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