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

• 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: EUCTR2009-014490-41-IT
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 670

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 AH; - Documented hemodynamic diagnosis of PAH.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 447
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 223

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