CompletedPhase 2

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

United States63 participantsStarted 2014-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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)

What they're measuring

Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment

Timeframe: From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day

Trial details

NCT IDNCT02070991

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11-01

Results submitted2019-01-30

View on ClinicalTrials.gov More Pulmonary Hypertension trials