Phase 2
N=76
Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02060721 ↗Enrolled (actual)
76
Serious AEs
57.9%
Results posted
Apr 2023
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 72 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Macitentan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actelion
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
72 | — |
| PRIMARY Number of Participants With AEs Leading to Study Drug Discontinuation |
9 | — |
| PRIMARY Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) |
44 | — |
| PRIMARY Number of Participants With Hemoglobin Abnormalities |
0; 7; 7; 6; 32; 31 | — |
| PRIMARY Number of Participants With Liver Tests Abnormalities |
2; 1; 1; 0; 1; 8 | — |
| PRIMARY Change From Baseline in Blood Pressure at Month 6 |
-0.4; -2.8 | — |
| PRIMARY Change From Baseline in Pulse Rate at Month 6 |
-1.1 | — |
| PRIMARY Change From Baseline in Body Weight at Month 6 |
-0.35 | — |
Summary
Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).
- Females of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception.
Exclusion Criteria
- Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
- Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.
Data sourced from ClinicalTrials.gov (NCT02060721). 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.