Phase 3
Completed N=709
ACT-293987 in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT01112306 ↗
Enrolled (actual)
709
Serious AEs
59.2%
Results posted
Sep 2022
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation — 684 Participants
◆ Published Evidence
Established
33citations · ~8 / year
Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension.
Summary
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)
Linked Publications
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Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation |
684 | — |
| PRIMARY Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation |
420 | — |
| PRIMARY Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention |
129 | — |
| SECONDARY Percentage of Alive Participants |
100; 98.4; 96.3; 94.0; 92.0; 85.3 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01112306) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.