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Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension Due to Left Ventricular Dysfunction (MELODY-1)

This study has been completed.
Information provided by (Responsible Party):
Actelion Identifier:
First received: February 21, 2014
Last updated: December 15, 2015
Last verified: December 2015
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.

Condition Intervention Phase
Pulmonary Hypertension
Drug: Macitentan
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week 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

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • Proportion of subjects experiencing significant fluid retention or worsening in NYHA functional class from baseline [ Time Frame: Baseline to End of Study, up to Week 12 (plus post-treatment safety follow-up of at least 30 days after permanet discontinuation of study treatment) ] [ Designated as safety issue: Yes ]
    Significant fluid retention, defined as one of the following: a.Increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload. b.Parenteral administration of diuretics.

Secondary Outcome Measures:
  • Percentage of change from baseline in pulmonary vascular resistance (PVR) to Week 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    PVR was assessed at rest by right heart catheterization

Enrollment: 60
Study Start Date: July 2014
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macitentan
oral tablet, 10 mg once daily.
Drug: Macitentan
oral tablet, 10 mg once daily
Other Name: ACT-064992
Placebo Comparator: Placebo
Matching placebo, once daily.
Drug: Placebo
matching placebo
Other Name: matching placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT02070991

  Show 32 Study Locations
Sponsors and Collaborators
Study Chair: Sébastien Roux, PhD Actelion
  More Information

Responsible Party: Actelion Identifier: NCT02070991     History of Changes
Other Study ID Numbers: AC-055G201 
Study First Received: February 21, 2014
Last Updated: December 15, 2015
Health Authority: Switzerland: Swissmedic
United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Israel: Ethics Commission
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Austria: Federal Office for Safety in Health Care
Canada: Health Canada

Keywords provided by Actelion:
pre- and post-capillary pulmonary hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Ventricular Dysfunction, Left
Ventricular Dysfunction
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists processed this record on October 26, 2016