ACT-293987 in Pulmonary Arterial Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112306
Recruitment Status : Active, not recruiting
First Posted : April 28, 2010
Last Update Posted : June 13, 2018
Information provided by (Responsible Party):

April 8, 2010
April 28, 2010
June 13, 2018
December 1, 2009
February 1, 2021   (Final data collection date for primary outcome measure)
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. ]
Same as current
Complete list of historical versions of study NCT01112306 on Archive Site
Not Provided
Not Provided
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ACT-293987 in Pulmonary Arterial Hypertension
Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of Selexipag (ACT-293987) in Patients With Pulmonary Arterial Hypertension
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)
Not Provided
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: ACT-293987
Tablets, twice daily
Experimental: 1
ACT-293987, twice daily
Intervention: Drug: ACT-293987
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
February 1, 2021
February 1, 2021   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belarus,   Belgium,   Canada,   Chile,   China,   Colombia,   Czechia,   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
Czech Republic
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Study Director: Aline Frey Actelion
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP