A 24-WEEK MULTICENTRE, RANDOMISED, DOUBLE BLIND, CONTROLLED, PARALLEL GROUP NON-INFERIORITY STUDY TO ASSESS THE EFFICACY AND SAFETY OF OLMESARTAN MEDOXOMIL VERSUS CANDESARTAN CILEXETIL IN PATIENTS WITH SYMPTOMATIC HEART FAILURE (NYHA II-IV) - OLMEBNP
- Conditions
- Patients with symptomatic, clinically stable CHF with left ventricular systolic dysfunction [NYHA class II-IV and left ventricular ejection fraction (LVEF) < 40%] and elevated BNP levels (>400 pg/ml or NT-ProBNP levels > 1500 pg/ml), within 90 days after discharge from a heart failure hospitalisation.MedDRA version: 9.1Level: LLTClassification code 10008908Term: Chronic heart failure
- Registration Number
- EUCTR2007-003060-22-FR
- Lead Sponsor
- DAIICHI SANKYO EUROPE GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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 < 40% assessed within the last 3 months,
Patients with blood BNP levels > 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
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 If a female becomes pregnant during the study, she has to be withdrawn immediately.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) < 50 bpm].
Patients with hypotension [systolic blood pressure (SBP) < 90 mmHg].
Patients with obstructive pneumopathy.
Patients with clinical significant renal failure (creatininemia > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method