Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension Due to Left Ventricular Dysfunction (MELODY-1)
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.
Pre-capillary Pulmonary Hypertension
Post-capillary Pulmonary Hypertension
Left Ventricular Dysfunction
|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|
- 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:
- Increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload.
- Parenteral administration of diuretics.
- Worsening in NYHA functional class from baseline.
- 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).
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
oral tablet, 10 mg once daily.
oral tablet, 10 mg once daily
Placebo Comparator: Placebo
Matching placebo, once daily.
Other Name: matching placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT02070991
Show 27 Study Locations
|Study Chair:||Sébastien Roux, PhD||Actelion|