Clinical Trials Directory

Trials / Completed

CompletedNCT02382016

PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial

A Randomized, Double-blind, Placebo-controlled, Prospective, Multicenter, Parallel Group Study to Assess the Safety and Efficacy of Macitentan in Patients With Portopulmonary Hypertension

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
85 (actual)
Sponsor
Actelion · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.

Conditions

Interventions

TypeNameDescription
DRUGMacitentanMacitentan film-coated tablet 10 mg once daily.
OTHERPlaceboMatching placebo tablet once daily.

Timeline

Start date
2015-06-23
Primary completion
2017-10-25
Completion
2018-10-31
First posted
2015-03-06
Last updated
2025-03-30
Results posted
2018-11-23

Locations

52 sites across 7 countries: United States, Brazil, Czechia, France, Germany, Spain, United Kingdom

Source: ClinicalTrials.gov record NCT02382016. Inclusion in this directory is not an endorsement.

PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial (NCT02382016) · Clinical Trials Directory