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 (MELODY-1)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Pulmonary Hypertension

Treatments: Drug: Placebo; Drug: Macitentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02070991

AC-055G201

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and Females >=18 years of age
2. Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
3. Optimized diuretic therapy

Exclusion criteria

1. Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
2. Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

63 participants in 2 patient groups, including a placebo group

Macitentan

Experimental group

Description:

oral tablet, 10 mg once daily.

Treatment:

Drug: Macitentan

Placebo

Placebo Comparator group

Description:

Matching placebo, once daily.

Treatment:

Drug: Placebo