Phase 2
N=63
Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02070991 ↗Enrolled (actual)
63
Serious AEs
27.0%
Results posted
May 2019
Primary outcome: Primary: Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment — 7; 4; 7; 3 Participants — p=0.3372
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Macitentan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actelion
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment |
7; 4; 7; 3; 1; 2 | 0.3372 |
| SECONDARY NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest |
91.56; 118.90 | — |
| SECONDARY PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest |
66.31; 71.23 | — |
| SECONDARY Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP) |
44.6; 45.9; 41.1; 42.1; -3.5; -3.8 | — |
| SECONDARY Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) |
12.1; 13.0; 11.2; 11.3; -0.9; -1.6 | — |
| SECONDARY Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP) |
19.1; 19.7; 19.9; 20.8; 0.8; 1.1 | — |
| SECONDARY Change From Baseline to Week 12 in Cardiac Index (CI) |
2.32; 2.33; 2.69; 2.30; 0.37; -0.03 | — |
| SECONDARY Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG) |
11.8; 11.4; 7.0; 7.0; -4.8; -4.3 | — |
Summary
Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.
Eligibility Criteria
Inclusion Criteria
- Males and Females >=18 years of age
- Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
- Optimized diuretic therapy
Exclusion Criteria
- Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
- Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)
Data sourced from ClinicalTrials.gov (NCT02070991). 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.