Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2009-014490-41-BE
• Date of registration: 23/11/2009
• Prospective Registration: Yes
• Primary sponsor: Actelion Pharmaceuticals Ltd
• Public title: Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.
• 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 - GRIPHON
• Date of first enrolment: 22/02/2010
• Target sample size: 1150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014490-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

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: Global Medical Information
• Affiliation: Actelion Pharmaceuticals Ltd.

• Name: Global Medical Information
• Affiliation: Actelion Pharmaceuticals Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
- Signed informed consent prior to initiation of any study-mandated procedure.
- Male and female patients aged from 18 years to 75 years inclusive with symptomatic PAH.
- Documented hemodynamic diagnosis of PAH.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Patients who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 15.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: ACT-293987
Product Code: ACT-293987
Pharmaceutical Form: Tablet
INN or Proposed INN: Selexipag
Current Sponsor code: ACT-293987
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: It's an event-driven trial.

Main Objective: To demonstrate the effect of ACT-293987 on time to first
morbidity and mortality (MM) event in patients with pulmonary
arterial hypertension (PAH).

Primary end point(s): Time to first CEC-confirmed Morbidity and mortality event (MM), up to 7 days after last study drug intake defined as:
• Death (all-cause mortality)
• Hospitalization for worsening of PAH
• Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy
• Initiation of parenteral prostanoid therapy or chronic oxygen therapy due to worsening of PAH
• Disease progression

MM events will be adjudicated in a blinded fashion by an independent Critical Event Committee.

Secondary Objective: To evaluate the effect of ACT-293987 on exercise capacity and other secondary and exploratory efficacy endpoints in patients with PAH.

To evaluate the safety and tolerability of ACT-293987 in patients with PAH.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: NA

Secondary end point(s): NA

Secondary ID(s)

AC-065A302

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd.