Heart failure with preserved ejection fraction and pulmonary vascular disease MedDRA version: 20.1 Level: LLT Classification code 10076396 Term: Heart failure with preserved ejection fraction System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Concentration unit: mg milligram(s
Sponsors
ACTELION Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signs or symptoms of Heart Failure (HF) (NYHA FC II and III) requiring treatment with at least one oral diuretic (any type) • Left Ventricular ejection fraction (LVEF) = 40% (by echocardiography at Screening) • Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF) established by echocardiography at Screening • Elevated NT-proBNP • Pulmonary vascular disease or right ventricular dysfunction Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: • Any prior valid measurement of LVEF < 40%. • Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia; history of or anticipated heart transplant or ventricular assist device implantation, etc) • Systolic blood pressure (SBP) = 180 mmHg, or diastolic blood pressure (DBP) = 110 mmHg during Screening • Hemoglobin < 100g/L (< 10 g/dl). • Significant parenchymal lung disease (e .g., severe COPD, moderate or severe restrictive lung disease , diffuse interstitial fibrosis or alveolitis, pulmonary thromboembolism) • Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR ) < 30 m L/min per 1.73 m2 • Severe hepatic impairment, e .g., Child Pugh Class C. Other protocol-defined inclusion/exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate whether macitentan 10 mg reduces NT-pro-BNP versus placebo at Week 24 in subjects with HFpEF and pulmonary vascular disease;Secondary Objective: The secondary objective of the study is to evaluate the effect of macitentan 10 mg as compared to placebo on: – Quality of life – Daily physical activity – Worsening of heart failure;Primary end point(s): Primary efficacy endpoint(s) • Percent of baseline NT-proBNP assessed at Week 24;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints • Change from baseline to Week 24 in the clinical summary score (as assessed by the Kansas City Cardiomyopathy Questionnaire [KCCQ]) • Change from baseline to Week 24 in accelerometer-assessed proportion of time spent in light to vigorous physical activity based on a threshold of > 100 activity counts per minute • Time to worsening heart failure (WHF) event over 52 weeks as adjudicated by the Clinical Event Committee;Timepoint(s) of evaluation of this end point: Week 24, Week 52 | — |
Countries
Austria, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, Israel, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClinical trial disclosure desk
ACTELION Pharmaceuticals Ltd
Outcome results
None listed