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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Europe, GmbH; Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
• Treatments: Candesartan; Candesartan cilexetil; Olmesartan; Olmesartan Medoxomil

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 If a female becomes pregnant during the study, she has to be withdrawn immediately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