Selexipag (ACT-293987) in Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01106014
• Date of registration: 02/04/2010
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: Selexipag (ACT-293987) in Pulmonary Arterial Hypertension GRIPHON
• Scientific title: A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension
• Date of first enrolment: December 2009
• Target sample size: 1156
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01106014
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Aline Frey
• Affiliation: Actelion

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Selexipag

Drug: Placebo

Primary Outcome(s)

Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake [Time Frame: Up to 7 days after end of double-blind treatment (maximum: 4.3 years)]

Secondary Outcome(s)

Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC) [Time Frame: Week 26]

Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough [Time Frame: Week 26]

Secondary ID(s)

AC-065A302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/03/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01106014