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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014490-41-DK

Enrollment

1150

Registered

2009-11-23

Start date

2009-12-08

Completion date

Unknown

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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).;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.;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.;Timepoint(s) of evaluation of this end point: It's an event-driven trial.	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

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

Public ContactGlobal Medical Information

Actelion Pharmaceuticals Ltd

medinfo_ch@actelion.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026