Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

Phase 3

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Epoprostenol

• Registration Number: NCT01470144
• Lead Sponsor: Actelion

Brief Summary

This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-01
• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-11
• Primary Completion: 2015-06-01
• Study Completion: 2015-07-01
• Results First Submitted: 2016-10-18
• Results First Submitted QC: 2016-10-18
• Results First Posted: 2016-12-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Signed informed consent prior to initiation of any study-mandated procedure
2. Patients who completed participation in study AC-066A301
3. Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301

Exclusion Criteria

1. Patients who prematurely discontinued study drug in study AC-066A301
2. Patients for whom continued treatment with EFI is no longer considered appropriate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Epoprostenol	Single arm, open-label

Primary Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events	On average 2.72 years

Secondary Outcome Measures

Name	Time	Method
Exposure Duration	On average 2.72 years	Duration of exposure to EFI

Trial Locations

Locations (8)

University of Toronto; 🇨🇦 Toronoto, Ontario, Canada

CHU Caen; 🇫🇷 Caen, France

Ospedale Sant'Orsola; 🇮🇹 Bologna, Italy

Hôpital Kremlin Bicêtre; 🇫🇷 Paris, France

VUMC; 🇳🇱 Amsterdam, Netherlands

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

Sir Mortimer B Davis Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada