CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 742 enrolled
Drug / intervention
macitentan (ACT-064992) +2 moredrug
Likely dose
macitentan (ACT-064992) 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00660179
NCT00660179Phase 3Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

Actelion·interventional·Posted Apr 17, 2008·Updated Sep 28, 2015

In Brief

A Phase 3 clinical trial evaluating macitentan (ACT-064992) and placebo for Pulmonary Arterial Hypertension. Completed, enrolled 742 participants across 153 sites in 38 countries.

Detailed Summary

The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesArgentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2008
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2012
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.2 years ago

Interventions

macitentan (ACT-064992)drug

Tablet, 3 mg dosage, once daily

macitentan (ACT-064992)drug

Tablet, 10 mg dosage, once daily

placebodrug

Matching placebo, once daily