Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

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Official title:

An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470144
• Other study ID #: AC-066A302
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2011
• Last updated: December 14, 2015
• Start date: June 2011
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaCanada: Ethics Review CommitteeItaly: Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health ProductsSpain: Agencia Española de Medicamentos y Productos SanitariosFrance: Committee for the Protection of PersonnesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg - Site 201	Leuven
Canada	Sir Mortimer B Davis Jewish General Hospital	Montreal	Quebec
Canada	Univesrity of Toronto	Toronoto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment-emergent adverse events	treatment-emergent adverse events up to 24 hours post end of trial	up to 24 hours post trial	Yes
Secondary	adverse events	safety endpoint of adverse events leading to premature discontinuation of study drug	Baseline to end of study (3 months)	Yes