A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO DEMONSTRATE THE EFFICACY AND SAFETY OF ACT-293987 IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSIO

Not Applicable

• Conditions: -I270 Primary pulmonary hypertension; Primary pulmonary hypertension; I270

• Registration Number: PER-064-10
• Lead Sponsor: Actelion Pharmaceuticals Ltd,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Male and female patients 18-75 years old, with symptomatic PAH
• PAH belonging to the following subgroups of the updated Dana Point Clinical Classification Group 1 (Idiopathic, or Heritable, or Drug or toxin induced, or Associated (APAH) with Connective tissue disease, Congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair, or HIV infection)
• Documented hemodynamic diagnosis of PAH by right heart catheterization, performed at any time prior to Screening
• Six minute walk distance (6MWD) between 50 and 450 m at Screening within 2 weeks prior to the Baseline Visit
• Signed informed consent

Exclusion Criteria

• Patients with pulmonary hypertension (PH) in the Updated Dana Point Classification Groups 2-5, and PAH Group 1 subgroups that are not covered by the inclusion criteria
• Patients who have received prostacyclin or its analogs 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
• Patients who are receiving or have been receiving any investigational drugs within 1 month before the Baseline Visit
• Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6MWT
• Recently conducted or planned cardio-pulmonary rehabilitation program based on exercise training
• Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
• Life expectancy less than 12 months
• Females who are lactating or pregnant or plan to become pregnant during the study
• Known hypersensitivity to any of the excipients of the drug formulations

Study & Design

• Study Type: Interventional
• Study Design: Not specified