Phase 3
Completed N=1,156
Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT01106014 ↗Enrolled (actual)
1,156
Serious AEs
45.5%
Results posted
Mar 2016
Primary outcomePrimary: Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake — 91.2; 81.7; 83.1; 70.6 Percentage of patients free of events — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake |
91.2; 81.7; 83.1; 70.6; 75.5; 61.3 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough |
376; 369; 370; 346; 4; -9 | 0.0027 sig |
| SECONDARY Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC) |
77.8; 74.9 | 0.2843 |
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
Data sourced from ClinicalTrials.gov (NCT01106014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.