ACT-293987 in Pulmonary Arterial Hypertension
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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. |
ClinicalTrials.gov Identifier: NCT01112306 |
Recruitment Status :
Completed
First Posted : April 28, 2010
Last Update Posted : January 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Arterial Hypertension | Drug: ACT-293987 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1213 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension |
Actual Study Start Date : | July 7, 2010 |
Actual Primary Completion Date : | August 26, 2021 |
Actual Study Completion Date : | August 26, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
ACT-293987, twice daily
|
Drug: ACT-293987
Tablets, twice daily |
- 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. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112306

Study Director: | Aline Frey | Actelion |
Responsible Party: | Actelion |
ClinicalTrials.gov Identifier: | NCT01112306 |
Other Study ID Numbers: |
AC-065A303 2009-014992-31 ( EudraCT Number ) |
First Posted: | April 28, 2010 Key Record Dates |
Last Update Posted: | January 5, 2022 |
Last Verified: | January 2022 |
Open-label PAH Pulmonary Arterial Hypertension |
Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases Cardiovascular Diseases |
Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Selexipag Antihypertensive Agents |