Selexipag (ACT-293987) in Pulmonary Arterial Hypertension

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID

NCT01106014

Run by

Actelion

People needed

1156

Starts

2009-12-01

Expected to finish

2014-10-01

Last updated by the study team

2025-10-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Arizona, Clinical and Translational Science (CATS) Research Center — Tucson, Arizona, United States
• University of California San Diego Medical Center (La Jolla) — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• GLVA Healthcare Center — Los Angeles, California, United States
• University of California, Davis, UC Davis Medical Center — Sacramento, California, United States
• LIU Center for Pulmonary Hypertension — Torrance, California, United States
• Lung Health & Sleep Emhancement Center, LLC — Newark, Delaware, United States
• Emory University School of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine — Atlanta, Georgia, United States
• Georgia Health Sciences University — Augusta, Georgia, United States
• Georgia Clinical Research — Austell, Georgia, United States
• Clarian North Hospital — Carmel, Indiana, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• LSU Health Science Center - New Orleans — New Orleans, Louisiana, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital - Pulmonary Critical Care Unit — Boston, Massachusetts, United States
• Massachusetts General Hospital-Pulmonary Critical Care Unit — Boston, Massachusetts, United States
• Boston University School of Medicine / Boston University Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Beaumont Hospital — Troy, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Newark Beth Isreal Medical Center-Department of Pulmonary Medicine — Newark, New Jersey, United States
• University of South Alabama — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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