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

Phase 1

• Conditions: The intended indication is Pulmonary Arterial Hypertension; MedDRA version: 19.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-014992-31-SE
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-14
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1150

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 Patients who have experienced a morbidity event (confirmed by the Critical Event Committee [CEC]) during study AC-065A302, or Patients experiencing a worsening of PAH during the Treatment Extension period of AC-065A302 and for whom a written approval to roll over into this study has been obtained from the sponsor.
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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. Pediatric patients (i.e., < 18 years of age).
2. Patients who are not able to perform the Visit 1 of AC- 065A303/GRIPHON OL within 2 weeks (i.e., 14 days) of the last visit in AC-065A302/GRIPHON.
3. Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in AC-065A302/GRIPHON.
4. Severe hepatic impairment (Child-Pugh C).
5. Females who are pregnant or plan to become pregnant during the study, or are breastfeeding.
6. 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.
7. Known hypersensitivity to selexipag or any of the excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified