The intended indication is Pulmonary Arterial Hypertension MedDRA version: 18.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Actelion Pharmaceuticals Ltd
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and tolerability of selexipag in patients with pulmonary arterial hypertension (PAH).;Secondary Objective: NA;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. | — |
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
Outcome results
None listed