CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
ACT-385781A (Actelion Epoprostenol) +1 moredrug
Likely dose
Not stated in 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/NCT01105091
NCT01105091Phase 4Completed
CompareCT.gov

A Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)

Actelion·interventional·Posted Apr 16, 2010·Updated Feb 4, 2025

In Brief

A Phase 4 clinical trial evaluating ACT-385781A (Actelion Epoprostenol) and Flolan® for Pulmonary Arterial Hypertension. Completed, enrolled 30 participants.

Detailed Summary

This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and Flolan (epoprostenol sodium) in patients with pulmonary arterial hypertension who are naïve to injectable prostanoid treatment and in need of such treatment. Approximately 30 patients from 8 U.S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2:1 respectively) for 28 days of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 16, 2010
Enrollment StartMar 1, 2010
Primary CompletionMay 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.2 years ago

Interventions

ACT-385781A (Actelion Epoprostenol)drug

per Prescribing Information

Flolan®drug

Per Prescribing Information