Phase 2
Completed N=80
Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Source: ClinicalTrials.gov NCT02021292 ↗
Enrolled (actual)
80
Serious AEs
12.5%
Results posted
Jan 2018
Primary outcomePrimary: Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. — 73.0; 87.2 percent of baseline PVR — p=0.0410
Summary
Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. |
73.0; 87.2 | 0.0410 sig |
| SECONDARY Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD). |
353.0; 351.2; 388.0; 352.2; 35.0; 1.0 | 0.0326 sig |
| SECONDARY Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT). |
4.2; 4.2; 4.1; 4.4; -0.1; 0.3 | 0.3492 |
| SECONDARY Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24 |
0; 0; 12; 6; 28; 33 | 0.0962 |
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the obstruction being surgically inaccessible (i.e., distal disease).
- Female 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
- Previous pulmonary endarterectomy.
- Recurrent thromboembolism despite sufficient oral anticoagulants.
- Symptomatic acute pulmonary embolism in the 6-month period prior to randomization.
- Known moderate-to-severe restrictive lung disease (i.e., TLC < 60% of predicted value) or obstructive lung disease (i.e., FEV1 < 70% of predicted, with FEV1/FVC < 65%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema).
- Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements in the 3-month period prior to Screening visit or during the Screening period.
Data sourced from ClinicalTrials.gov (NCT02021292). 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.