NCT02060721

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

MERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Long-term study to evaluate if macitentan is safe, tolerable and efficient 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 10mg, oral tablet, once daily

Timeline

• Start date: 2015-02-03
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2014-02-12
• Last updated: 2025-03-30
• Results posted: 2023-04-11

Locations

33 sites across 15 countries: Belgium, China, Czechia, France, Germany, Hungary, Lithuania, Mexico, Poland, Russia, Switzerland, Thailand, Turkey (Türkiye), Ukraine, United Kingdom