NCT02070991

Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction

A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Macitentan	oral tablet, 10 mg once daily
DRUG	Placebo	matching placebo

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-02-25
• Last updated: 2019-05-15
• Results posted: 2019-05-15

Locations

32 sites across 11 countries: United States, Austria, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Spain, Switzerland