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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 is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT02070991
First received: February 21, 2014
Last updated: August 28, 2014
Last verified: August 2014
  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

Locations
United States, California
LIU Center for Pulmonary Hypertension Not yet recruiting
Torrance, California, United States, 90502
Contact: Ronald Oudiz    310-222-2515    roudiz@labiomed.org   
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: John W. McConnell    502-587-8000    mcco3526@bellsouth.net   
United States, Massachusetts
Boston University School of Medicine Recruiting
Boston, Massachusetts, United States, 02118
Contact: Harrison W Farber    617-638-4860    hfarber@bu.edu   
United States, Michigan
University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Vallerie McLaughlin    734-936-5383    vmclaugh@med.umich.edu   
Austria
Medical University of Vienna and AKH Cardiology Recruiting
Vienna, Austria, A-1090
Contact: Diana Bonderman    +43 1 40 400 46 14    diana.bonderman@meduniwien.ac.at   
Belgium
Hôpital Erasme, Cliniques Universitaires de Bruxelles, Cardiologie Recruiting
Brussels, Belgium, 1070
Contact: Jean-Luc Vachiéry    +32-2-555 39 14    jeanluc.vachiery@erasme.ulb.ac.be   
University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie Recruiting
Leuven, Belgium, 3000
Contact: Marion Delcroix    +32 16 34 68 33    marion.delcroix@uzleuven.be   
Israel
Carmel Medical Center, Pulmonary Unit Not yet recruiting
Haifa, Israel, 34362
Contact: Yochai Adir    972-4-8250517    yochaiad@clalit.org.il   
Institute of Pulmonology Hadassah Medical Centre : Ein Karem Recruiting
Jerusalem, Israel, 91120
Contact: Neville Berkman    +972 2 677 77 83    neville@hadassah.org.il   
Kaplan Medical Centre / Pulmonary Institute and Department of Medicine Not yet recruiting
Rehovot, Israel, 76100
Contact: Daniel Starobin    +972 8 9441211    daniel_s@clalit.org.il   
The Chaim Sheba Medical Center / The Institute of Pulmonology, Physiology and Exercise Recruiting
Tel-Hashomer, Israel, 52621
Contact: Michael Segel    +972-3-530-3030    Michael.Segel@gmail.com   
Italy
A.O. Universitaria Policlinico S. Orsola-Malpighi - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale - Unità Operativa di Cardiologia Not yet recruiting
Bologna, Italy, 40138
Contact: Nazzareno Galiè    +39 051 6363434    nazzareno.galie@unibo.it   
Spain
Hospital Clinic Servicio de Cardiologia Recruiting
Barcelona, Spain, 08036
Contact: Félix Pérez Villa    +34 932275400 ext. 2035    fperez@clinic.ub.es   
Hospital Vall d´Hebron Servicio de Cardiologia Recruiting
Barcelona, Spain, 08035
Contact: Enric Domingo Ribas    +34 93 489 30 00    edrcg@hotmail.com   
Hospital Reina Sofia Servicio de Cardiologia Recruiting
Cordoba, Spain, 14004
Contact: José María Arizón del Prado    +34 957 010 504    josem.arizon.sspa@juntadeandalucia.es   
Hospital Universitario 12 Octubre Servicio de Cardiología Not yet recruiting
Madrid, Spain, 28041
Contact: Miguel Angel Gomez Sanchez    (+) 34 91390 8289    mangomezs@telefonica.net   
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: August 28, 2014
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 November 20, 2014