Phase 3
Completed N=550
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT00667823 ↗Enrolled (actual)
550
Serious AEs
64.4%
Results posted
Feb 2022
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation — 527 Participants
◆ Published Evidence
Emerging
18citations · ~5 / year
Long-Term Safety, Tolerability and Survival in Patients with Pulmonary Arterial Hypertension Treated with Macitentan: Results from the SERAPHIN Open-Label Extension.
Summary
The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
Linked Publications (2)
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Long-Term Safety, Tolerability and Survival in Patients with Pulmonary Arterial Hypertension Treated with Macitentan: Results from the SERAPHIN Open-Label Extension.
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Modeling of pharmacokinetics, efficacy, and hemodynamic effects of macitentan in patients with pulmonary arterial hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation |
527 | — |
| PRIMARY Number of Participants With Death up to 28 Days After Study Treatment Discontinuation |
175 | — |
| PRIMARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation |
354 | — |
| PRIMARY Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment |
62 | — |
| PRIMARY Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation |
45; 20; 11; 75; 8 | — |
| PRIMARY Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation |
33; 98; 188; 29 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent prior to initiation of any study-mandated procedure.
- Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
- Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.
Exclusion Criteria
- Any major violation of protocol AC 055 302/SERAPHIN.
- Pregnancy or breast-feeding.
- AST and/or ALT > 3 times the upper limit of the normal range.
- 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.
- Known hypersensitivity to ACT 064992 or any of the excipients.
Data sourced from ClinicalTrials.gov (NCT00667823) 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.