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

Phase 3

• Conditions: Health Condition 1: null- Pulmonary Arterial Hypertension

• Registration Number: CTRI/2011/06/001842
• Lead Sponsor: ACTELION Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 670

Inclusion Criteria

1. Signed informed consent prior to initiation of any study-mandated procedure.

2. Male and female patients aged from 18 years to 75 years inclusive with symptomatic PAH.

3. Documented hemodynamic diagnosis of PAH.

Exclusion Criteria

1. 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.

2. Patients with moderate or severe obstructive lung disease.

3. Patients with moderate or severe restrictive lung disease.

4. Patients with moderate or severe hepatic impairment (Child-Pugh B and C).

5. Patients with documented left ventricular dysfunction.

6. Patients with severe renal insufficiency.

7. Patients with BMI 18.5 Kg/m2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified