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