Selexipag (ACT-293987) in Pulmonary Arterial Hypertension

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Selexipag

Criteria

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