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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT02070991
First received: February 21, 2014
Last updated: February 16, 2017
Last verified: February 2017
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 up to end-of-treatment [ Time Frame: From randomization up to End of Study: treatment period up to Week 12 ]
    Composite endpoint of significant fluid retention (defined as an increase in body weight due to fluid overload by ≥ 5kg or ≥ 5%, or intravenous administration of diuretics) or a worsening of NYHA functional class from baseline


Secondary Outcome Measures:
  • NT-Pro-BNP at Week 12 Expressed As Percent of Baseline NT-Pro-BNP at Week 12 [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  • PVR at rest at Week 12 expressed as percent of Baseline PVR at rest [ Time Frame: From randomization up to end of treatment period (Week 12) ]
    PVR was assessed at rest by right heart catheterization

  • Mean Pulmonary Arterial Pressure - Change from Baseline to Week 12 [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  • Mean Right Atrial Pressure - Change from baseline to week 12 [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  • Pulmonary Artery Wedge Pressure - Change from Baseline to Week 12 [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  • Cardiac Index - Change from Baseline to Week 12 [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  • Diastolic Pulmonary V. Pressure Gradient - Change from Baseline to Week 12 [ Time Frame: From randomization up to end of treatment period (Week 12) ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070991

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

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02070991     History of Changes
Other Study ID Numbers: AC-055G201
Study First Received: February 21, 2014
Last Updated: February 16, 2017

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

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Ventricular Dysfunction
Ventricular Dysfunction, Left
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heart Diseases
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists

ClinicalTrials.gov processed this record on April 28, 2017