NCT02021292

Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).

Conditions

• Chronic Thromboembolic Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Macitentan	Macitentan 10 mg, oral tablet, to be taken once daily.
DRUG	Placebo	Matching placebo oral tablet, to be taken once daily.

Timeline

• Start date: 2014-08-20
• Primary completion: 2016-09-28
• Completion: 2016-09-28
• First posted: 2013-12-27
• Last updated: 2025-03-30
• Results posted: 2018-01-23

Locations

36 sites across 16 countries: Belgium, China, Czechia, France, Germany, Hungary, Lithuania, Mexico, Poland, Russia, South Korea, Switzerland, Thailand, Turkey (Türkiye), Ukraine, United Kingdom