An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection)

Conditions: Pulmonary Arterial Hypertension
MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2010-018320-10-NL

Lead Sponsor: ACTELION Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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 (i.e. reimbursement) to commercial EFI at the time of ending participation in study AC-066A301

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess safety and tolerability of Epoprostenol for injection in patients with PAH<br><br>;Secondary Objective: Not applicable;Primary end point(s): Tolerability / Safety endpoints:<br>• Treatment-emergent adverse events (AEs) up to 24 hours post-EOT<br>• Adverse events leading to premature discontinuation of study drug <br>• Treatment-emergent serious AEs (SAEs) up to 30 days post-EOT<br><br>;Timepoint(s) of evaluation of this end point: - Monthly phone call during the study<br>- End-of-Study Treatment (EOT) visit<br>- 24 hours following EOT (phone call)<br>- 30 days following EOT (phone call)

Secondary Outcome Measures