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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT02070991
First received: February 21, 2014
Last updated: January 12, 2015
Last verified: January 2015
  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
Pre-capillary Pulmonary Hypertension
Post-capillary Pulmonary Hypertension
Left Ventricular Dysfunction
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:
  • To evaluate the safety and tolerability of macitentan 10 mg in subjects with CpcPH [ Time Frame: Baseline to End of Study (30 days after last dose) ] [ Designated as safety issue: Yes ]

    Proportion of subjects experiencing one of the following up to EOT:

    • Significant fluid retention, defined as one of the following:

      1. Increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload.
      2. Parenteral administration of diuretics.
    • Worsening in NYHA functional class from baseline.


Secondary Outcome Measures:
  • To evaluate the efficacy of macitentan 10 mg in subjects with CpcPH [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    PVR at rest at Week 12 expressed as percent of baseline PVR at rest. Change from baseline to Week 12 in mean right atrial pressure, mPAP, cardiac index, cardiac output, total pulmonary resistance, transpulmonary gradient (TPG [mPAP − PAWP]), DPG and mixed venous oxygen saturation at rest. Change from baseline to Week 12 in echocardiographic parameters of diastolic and systolic function (i.e., LVEF, tricuspid annular plane systolic excursion, tricuspid regurgitation velocity, diastolic wall thickness of the septum and the left ventricular free wall, E/e' ratio, left atrial volume).


Estimated Enrollment: 60
Study Start Date: August 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 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 Names:
  • Macitentan
  • 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
Genders Eligible for Study:   Both
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 27 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Chair: Sébastien Roux, PhD Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02070991     History of Changes
Other Study ID Numbers: AC-055G201
Study First Received: February 21, 2014
Last Updated: January 12, 2015
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ethics Commission
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic
Canada: Health Canada

Keywords provided by Actelion:
Left heart failure LLT
Pulmonary Hypertension LLT
CpcPH

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Ventricular Dysfunction
Ventricular Dysfunction, Left
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2015