ACT-293987 in Pulmonary Arterial Hypertension - Full Text View

Purpose

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:

Genetics Home Reference related topics: pulmonary arterial hypertension

Drug Information available for: Selexipag

Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension

U.S. FDA Resources

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 2021
Estimated Primary Completion Date:	February 2021 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 ACT-293987, twice daily	Drug: ACT-293987 Tablets, twice daily

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 ClinicalTrials.gov identifier: NCT01112306

Show 155 Study Locations

Sponsors and Collaborators

Actelion

Investigators


Study Director:	Aline Frey	Actelion

More Information


Responsible Party:	Actelion
ClinicalTrials.gov Identifier:	NCT01112306 History of Changes
Other Study ID Numbers:	AC-065A303
Study First Received:	April 8, 2010
Last Updated:	September 12, 2016
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:


Open-label PAH Pulmonary Arterial Hypertension

Additional relevant MeSH terms:


Hypertension Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary	Lung Diseases Respiratory Tract Diseases Selexipag Antihypertensive Agents

ClinicalTrials.gov processed this record on September 28, 2016