Patients with symptomatic, clinically stable CHF with left ventricular systolic dysfunction [NYHA class II-IV and left ventricular ejection fraction (LVEF) 400 pg/ml or NT-ProBNP levels > 1500 pg/ml), within 90 days after discharge from a heart failure hospitalisation. MedDRA version: 9.1 Level: LLT Classification code 10008908 Term: Chronic heart failure
Conditions
Interventions
Trade Name: Olmetec 10 mg
Product Name: olmesartan medoxomil
Product Code: CS-866
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration
Sponsors
DAIICHI SANKYO EUROPE GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female, adult, out-patients aged between 18 and 85 years. Patients with documented hospital admission within the previous 3 months before randomisation with discharge diagnosis of CHF. Patients with functional NYHA class II-IV with LVEF 400 pg/ml or NT-ProBNP levels > 1500 pg/ml. Patients with CHF due to ischemic heart disease, idiopathic dilated cardiomyopathy (IDC), mitral or aortic insufficiency or hypertension. Patients with stable conventional treatment with diuretics, ACEI and/or beta-blockers and/or aldosterone antagonists for at least 2 months prior to randomisation, unless documented contraindication or intolerance. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Females who are pregnant or plan a pregnancy during the time of the trial, are nursing or are of childbearing potential and not using acceptable methods of contraception. If a female becomes pregnant during the study, she has to be withdrawn immediately. Patients with current hospitalisation due to heart failure. Patients with stroke or transient ischemic attack (TIA) within the last 3 months. Patients with acute coronary syndrome, myocardial infarction, coronary artery bypass or angioplasty within 3 months. Planned cardiac surgery, revascularisation or resynchronisation within the study period. Patients with operable valvular disease or significant obstructive cardiomyopathy. Patients with bradycardia [heart rate (HR) 200 micromol/l). Patients with clinically significant laboratory abnormalities including: - Aspartate aminotransferase (ASAT), Alanine aminotransferase (ALAT) or alkaline phosphatase (ALP) greater than 3 times the upper limit of the laboratory reference range, - Bilirubin greater than twice the upper limit of the laboratory reference range, - Haemoglobin < 9 g/dl or < 90 g/l or 5.586 mmol/l. Patients who used ARB (including olmesartan medoxomil and candesartan cilexetil) for more than 7 consecutive days within the last 3 months. Patients with a beta-blocker therapy initiated less than 3 months before randomisation Patients with history of intolerance/ hypersensitivity to ARB, or to drugs with similar chemicals. Patients with autoimmune diseases, collagenosis, insulin-dependent or poorly controlled diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of olmesartan medoxomil versus candesartan cilexetil in reducing blood BNP levels at week 24.;Secondary Objective: To assess changes in BNP at week 4, 8, 16 and 24, To assess proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points), To assess cardiovascular events and deaths occurring within 24 weeks of treatment, To assess change in clinical status (improvement, no change, worsening).;Primary end point(s): Absolute BNP change from week 0 to 24 of treatment | — |
Countries
Czech Republic, France, Germany, Netherlands
Outcome results
None listed