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Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

NCT01470144 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-02-04

Study results available
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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.

Conditions

Interventions

DRUG

Epoprostenol

Administered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit

Sponsors & Collaborators

  • Chiltern International Ltd.

    collaborator INDUSTRY

  • Effi-Stat

    collaborator OTHER

  • Actelion

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-01
Primary Completion
2015-06-01
Completion
2015-07-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01470144 on ClinicalTrials.gov