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

• Register: EUCTR
• Last refreshed on: 29 November 2021
• Main ID: EUCTR2009-014992-31-DK
• Date of registration: 17/12/2009
• Prospective Registration: Yes
• Primary sponsor: Actelion Pharmaceuticals Ltd
• Public title: Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension
• Scientific title: Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL
• Date of first enrolment: 05/02/2010
• Target sample size: 1150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014992-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• 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:
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.


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: 19.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: selexipag
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-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: After Visit 5, safety will be assessed every six months.

Main Objective: To assess the long-term safety and tolerability of selexipag in patients with pulmonary arterial hypertension (PAH).

Secondary Objective: N/A

Primary end point(s): No primary efficacy endpoint is considered for this OL study. The primary endpoint for this study is safety and tolerability.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: N/A

Secondary end point(s): N/A

Secondary ID(s)

AC-065A303

2009-014992-31-BE

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd

Ethics review

Status: Approved
Approval date: 05/02/2010
Contact: