ACT-293987 in Pulmonary Arterial Hypertension

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Actelion Identifier:
First received: April 8, 2010
Last updated: November 17, 2015
Last verified: November 2015
Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: ACT-293987
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of Selexipag (ACT-293987) in Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to end of study. The duration of the study will be country-dependent and based on the results of the AC-065A302 study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 670
Study Start Date: December 2009
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ACT-293987, twice daily
Drug: ACT-293987
tablets, twice daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who participated to the double-blind study AC-065A302 and either had a morbidity event or had completed the study as scheduled per protocol.
  • Signed informed consent

Exclusion Criteria:

  • 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.
  • Severe hepatic impairment (Child-Pugh C)
  • Females who are pregnant or who plan to become pregnant during the study, or are breastfeeding.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01112306

  Show 161 Study Locations
Sponsors and Collaborators
Study Director: Aline Frey Actelion
  More Information

No publications provided

Responsible Party: Actelion Identifier: NCT01112306     History of Changes
Other Study ID Numbers: AC-065A303
Study First Received: April 8, 2010
Last Updated: November 17, 2015
Health Authority: Spain: Comité Ético de Investigación Clínica
United Kingdom: Research Ethics Committee
Switzerland: Swissmedic
China: Food and Drug Administration
Australia: National Health and Medical Research Council
United States: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Russia: Pharmacological Committee, Ministry of Health
Czech Republic: State Institute for Drug Control
Germany: Ethics Commission
Slovakia: State Institute for Drug Control
Romania: Ethics Committee
Taiwan: Institutional Review Board
Russia: Ministry of Health of the Russian Federation
Germany: Federal Institute for Drugs and Medical Devices
Russia: Ethics Committee
Canada: Ethics Review Committee
Denmark: Danish Medicines Agency
Thailand: Food and Drug Administration
Greece: National Organization of Medicines
Malaysia: Ministry of Health
Italy: Ethics Committee
Serbia: Ethics Committee
Australia: Human Research Ethics Committee
Ukraine: Ministry of Health
Singapore: Health Sciences Authority
Hungary: National Institute of Pharmacy
Slovak Republic: Ethics Committee
Sweden: Regional Ethical Review Board
Ukraine: State Pharmacological Center - Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Research Ethics Committee
Hungary: Research Ethics Medical Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Denmark: Ethics Committee
Israel: Ministry of Health
Netherlands: Medical Ethics Review Committee (METC)
Turkey: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Taiwan: National Bureau of Controlled Drugs
Greece: Ethics Committee
Sweden: Medical Products Agency
Singapore: Domain Specific Review Boards
Belarus: Ministry of Health
Israel: Ethics Commission
Romania: National Medicines Agency
United States: Institutional Review Board
Spain: Spanish Agency of Medicines
Taiwan: Department of Health
Austria: Federal Office for Safety in Health Care
India: Institutional Review Board
Czech Republic: Ethics Committee
South Korea: Institutional Review Board
Thailand: Ethical Committee
Ireland: Irish Medicines Board
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
France: Institutional Ethical Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: Drugs Controller General of India
Canada: Health Canada
Turkey: Ministry of Health
Belgium: Institutional Review Board

Keywords provided by Actelion:
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases processed this record on November 27, 2015