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

Phase 3

Terminated

• Conditions: Chronic Heart Failure; High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level
• Interventions: Drug: olmesartan medoxomil placebo + candesartan cilexetil; Drug: olmesartan medoxomil + candesartan cilexetil placebo

• Registration Number: NCT00679484
• Lead Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-16
• Study Start: 2008-06
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-08
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

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 If a female becomes pregnant during the study, she has to be withdrawn immediately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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	olmesartan medoxomil placebo + candesartan cilexetil	-
1	olmesartan medoxomil + candesartan cilexetil placebo	-

Primary Outcome Measures

Name	Time	Method
Absolute BNP change from week 0 to 24 of treatment	24 weeks

Secondary Outcome Measures

Name	Time	Method
Change in clinical status: Improvement: patient alive without any cardiovascular event with an improvement of at least one NYHA functional class level; No change: patient alive without any cardiovascular event with stable functional NYHA class	24 weeks
Proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points)	24 weeks maximum
BNP change from week 0 to week 4, 8, and 16	16 weeks maximum
Incidence of critical events at 24 weeks: All cause death; Cardiovascular death defined as death due to: HF, myocardial infarction, cardiac arrhythmia, stroke/cerebral vascular accident, other cardiovascular cause (e.g., aneurysm or pulmonary embolism)	24 weeks
Event-free survival	24 weeks
Time-to-first cardiovascular event	24 weeks maximum
Time-to-death	24 weeks