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: 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-DK
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-23
• Last Update Posted: 5 August 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the effect of ACT-293987 on time to first morbidity and mortality (MM) event in patients with pulmonary arterial hypertension (PAH).;Secondary Objective: To evaluate the effect of ACT-293987 on exercise capacity and other secondary and exploratory efficacy endpoints in patients with PAH.<br><br>To evaluate the safety and tolerability of ACT-293987 in patients with PAH.;Primary end point(s): Time to first CEC-confirmed Morbidity and mortality event (MM), up to 7 days after last study drug intake defined as:<br>• Death (all-cause mortality)<br>• Hospitalization for worsening of PAH<br>• Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy<br>• Initiation of parenteral prostanoid therapy or chronic oxygen therapy due to worsening of PAH<br>• Disease progression <br><br>MM events will be adjudicated in a blinded fashion by an independent Critical Event Committee.;Timepoint(s) of evaluation of this end point: It's an event-driven trial.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA