Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Selexipag; Placebo
Intervention description: Selexipag 200 µg tablets; Placebo tablets matching selexipag
Intervention MeSH terms: Selexipag
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1156.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: pulmonary arterial hypertension; PAH

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.
    

Eligibility 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