Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.

• Conditions: The intended indication is Pulmonary Arterial Hypertension; MedDRA version: 16.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-014490-41-AT
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-28
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1150

Inclusion Criteria

- Signed informed consent prior to initiation of any study-mandated procedure.
- Male and female patients aged from 18 years to 75 years inclusive with symptomatic PAH.
- Documented hemodynamic diagnosis of PAH.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) within 1 month before Baseline Visit, or are scheduled to receive any of these compounds during the trial.
- Patients with moderate or severe obstructive lung disease.
- Patients with moderate or severe restrictive lung disease.
- Patients with moderate or severe hepatic impairment (Child-Pugh B and C).
- Patients with documented left ventricular dysfunction.
- Patients with severe renal insufficiency.
- Patients with BMI <18.5 Kg/m2.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified