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Clinical trial

Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy

NCT03904693 is registered in ClinicalTrials.gov with Actelion as lead sponsor.

NCT NCT03904693
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Registry record

As filed in ClinicalTrials.gov.

Title
Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy
Lead sponsor
Actelion
Phase
Phase 3
Overall status
Completed
Start date
July 29, 2019
Completion date
September 27, 2024
Enrollment
187 (actual)
Sites
148

Conditions

As the registry lists them; a condition with its own page is linked.

pulmonary arterial hypertension (pah) (who group 1 ph)