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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

NCT ID: NCT00679484

Last Updated: 2018-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-11-30

Brief Summary

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

Detailed Description

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Conditions

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Chronic Heart Failure High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

olmesartan medoxomil + candesartan cilexetil placebo

Intervention Type DRUG

Dosage form: tablet; frequency: daily; duration: 24 weeks

2

Group Type EXPERIMENTAL

olmesartan medoxomil placebo + candesartan cilexetil

Intervention Type DRUG

Dosage form: tablets; frequency: daily; duration: 24 weeks

Interventions

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olmesartan medoxomil + candesartan cilexetil placebo

Dosage form: tablet; frequency: daily; duration: 24 weeks

Intervention Type DRUG

olmesartan medoxomil placebo + candesartan cilexetil

Dosage form: tablets; frequency: daily; duration: 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Daiichi Sankyo Europe GmbH

Locations

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Bron, , France

Site Status

Cedex, , France

Site Status

Cholet, , France

Site Status

Langres, , France

Site Status

Mannheim, , France

Site Status

Pontoise, , France

Site Status

Roubaix, , France

Site Status

Bad Nauheim, , Germany

Site Status

Berlin, , Germany

Site Status

Lambrecht, , Germany

Site Status

Ad Delft, , Netherlands

Site Status

Countries

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France Germany Netherlands

Other Identifiers

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2007-003060-22 EUDRACT Number

Identifier Type: -

Identifier Source: secondary_id

DSE-866-45

Identifier Type: -

Identifier Source: org_study_id