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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)

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ClinicalTrials.gov Identifier: NCT02070991
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Macitentan Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : July 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Macitentan

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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) ]
  2. 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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070991


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

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02070991     History of Changes
Other Study ID Numbers: AC-055G201
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
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