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.
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Recruiting
Sponsored by: Daiichi Sankyo Europe, GmbH Overall contact:
Faiez Zannad, MD, PhD, Phone: +33 383 65 66 25, Email: f.zannad@chu-nancy.fr
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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
Faiez Zannad, MD, PhD, Phone: +33 383 65 66 25, Email: f.zannad@chu-nancy.fr
Cholet, France; Recruiting
Langres, France; Recruiting
Pontoise, France; Recruiting
Bron, France; Recruiting
Roubaix, France; Recruiting
Cedex, France; Recruiting
Mannheim, France; Recruiting
Berlin, Germany; Recruiting
Lambrecht, Germany; Recruiting
Bad Nauheim, Germany; Recruiting
Ad Delft, Netherlands; Recruiting
Additional Information
Starting date: June 2008
Ending date: July 2010
Last updated: June 4, 2009
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