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
Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Heart Failure; High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level
Intervention: olmesartan medoxomil + candesartan cilexetil placebo (Drug); olmesartan medoxomil placebo + candesartan cilexetil (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Daiichi Sankyo Europe, GmbH
Summary
This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a
prognostic biomarker of heart failure, at week 24
Clinical Details
Official title: A 24-Week Multicentre, Randomized, 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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Absolute BNP change from week 0 to 24 of treatment
Secondary outcome: Proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points)BNP change from week 0 to week 4, 8, and 16 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) Event-free survival Time-to-death Time-to-first cardiovascular event 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
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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)
Locations and Contacts
Bron, France
Cedex, France
Cholet, France
Langres, France
Mannheim, France
Pontoise, France
Roubaix, France
Bad Nauheim, Germany
Berlin, Germany
Lambrecht, Germany
Ad Delft, Netherlands
Additional Information
Starting date: June 2008
Last updated: August 6, 2010
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