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

Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014992-31-SK

Enrollment

670

Registered

2010-06-09

Start date

2011-02-09

Completion date

Unknown

Last updated

2022-03-14

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: 14.0 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: 1. Signed informed consent prior to initiation of any study-mandated procedure. 2. Patients who have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study), or who have experienced a clinical worsening of PAH (adjudicated by the CEC) during study AC-065A302. 3. Women of child-bearing potential included in study AC-065A303 must use a reliable method of contraception (with a failure rate of less than 1% per year) until one month after study drug discontinuation. 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: 1. Any major violation of protocol AC-065A302. 2. Females who plan to become pregnant during the study, or are breastfeeding. 3. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence, or psychiatric disease. 4. Known hypersensitivity to ACT-293987 or any of the excipients.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the long-term safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension (PAH).;Secondary Objective: ;Primary end point(s): No primary efficacy endpoint is considered for this OL study. The primary endpoint for this study is safety and tolerability.;Timepoint(s) of evaluation of this end point: After Visit 5, safety will be assessed every six months.	—

Measure

Time frame

Main Objective: To assess the long-term safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension (PAH).;Secondary Objective: ;Primary end point(s): No primary efficacy endpoint is considered for this OL study. The primary endpoint for this study is safety and tolerability.;Timepoint(s) of evaluation of this end point: After Visit 5, safety will be assessed every six months.

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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