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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
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

Tracking Information
First Submitted Date  ICMJE February 21, 2014
First Posted Date  ICMJE February 25, 2014
Results First Submitted Date  ICMJE January 30, 2019
Results First Posted Date  ICMJE May 15, 2019
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE July 1, 2014
Actual Primary Completion Date November 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment [ Time Frame: From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day ]
The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2014)
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) ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest [ 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) ]
    Pulmonary vascular resistance (PVR) was assessed at rest by right heart catheterization (RHC).
  • Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP) [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  • Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  • Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP) [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  • Change From Baseline to Week 12 in Cardiac Index (CI) [ Time Frame: From randomization up to end of treatment period (Week 12) ]
  • Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG) [ Time Frame: From randomization up to end of treatment period (Week 12) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2014)
To evaluate the efficacy of macitentan 10 mg in subjects with CpcPH [ Time Frame: Baseline to Week 12 ]
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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE
  • Drug: Macitentan
    oral tablet, 10 mg once daily
    Other Name: ACT-064992
  • Drug: Placebo
    matching placebo
    Other Name: matching placebo
Study Arms  ICMJE
  • Experimental: Macitentan
    oral tablet, 10 mg once daily.
    Intervention: Drug: Macitentan
  • Placebo Comparator: Placebo
    Matching placebo, once daily.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2019)
63
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2014)
60
Actual Study Completion Date  ICMJE November 1, 2015
Actual Primary Completion Date November 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czechia,   France,   Germany,   Israel,   Italy,   Spain,   Switzerland,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02070991
Other Study ID Numbers  ICMJE AC-055G201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sébastien Roux, PhD Actelion
PRS Account Actelion
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP