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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00679484
Recruitment Status : Terminated (Lack of subject recruitment)
First Posted : May 16, 2008
Last Update Posted : December 24, 2018
Information provided by:
Daiichi Sankyo, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Heart Failure High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level Drug: olmesartan medoxomil + candesartan cilexetil placebo Drug: olmesartan medoxomil placebo + candesartan cilexetil Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 1 Drug: olmesartan medoxomil + candesartan cilexetil placebo
Dosage form: tablet; frequency: daily; duration: 24 weeks

Experimental: 2 Drug: olmesartan medoxomil placebo + candesartan cilexetil
Dosage form: tablets; frequency: daily; duration: 24 weeks

Primary Outcome Measures :
  1. Absolute BNP change from week 0 to 24 of treatment [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points) [ Time Frame: 24 weeks maximum ]
  2. BNP change from week 0 to week 4, 8, and 16 [ Time Frame: 16 weeks maximum ]
  3. 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) [ Time Frame: 24 weeks ]
  4. Event-free survival [ Time Frame: 24 weeks ]
  5. Time-to-death [ Time Frame: 24 weeks ]
  6. Time-to-first cardiovascular event [ Time Frame: 24 weeks maximum ]
  7. 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 [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00679484

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Bron, France
Cedex, France
Cholet, France
Langres, France
Mannheim, France
Pontoise, France
Roubaix, France
Bad Nauheim, Germany
Berlin, Germany
Lambrecht, Germany
Ad Delft, Netherlands
Sponsors and Collaborators
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

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Responsible Party: Senior Manager Clinical Development, Daiichi Sankyo Europe GmbH Identifier: NCT00679484     History of Changes
Other Study ID Numbers: DSE-866-45
2007-003060-22 EUDRACT Number
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: August 2010
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address:
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Additional relevant MeSH terms:
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Olmesartan Medoxomil
Heart Failure
Heart Diseases
Cardiovascular Diseases
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action