Study to Demonstrate the Non-inferiority of Olmesartan Medoxomil Versus Candesartan Cilexetil in Reducing Blood B-type (or Brain) Natriuretic Peptide Levels at Week 24 (OLMEBNP)

Daiichi Sankyo

Status and phase

Terminated

Phase 3

Conditions

Chronic Heart Failure

High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level

Treatments

Drug: olmesartan medoxomil + candesartan cilexetil placebo

Drug: olmesartan medoxomil placebo + candesartan cilexetil

Study type

Interventional

Funder types

Industry

Identifiers

DSE-866-45

2007-003060-22 EUDRACT Number

Details and patient eligibility

About

This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24

Enrollment

400 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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 randomization 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

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 If a female becomes pregnant during the study, she has to be withdrawn immediately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, revascularization or resynchronization 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)