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 - Full Text View

Sponsor:	Daiichi Sankyo Europe, GmbH
Information provided by:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00679484

Purpose

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

Condition	Intervention	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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: CV 11974 Olmesartan Olmesartan medoxomil Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Absolute BNP change from week 0 to 24 of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
BNP change from week 0 to week 4, 8, and 16 [ Time Frame: 16 weeks maximum ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Event-free survival [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Time-to-death [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Time-to-first cardiovascular event [ Time Frame: 24 weeks maximum ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	June 2008
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679484

Locations

France

Bron, France

Cedex, France

Cholet, France

Langres, France

Mannheim, France

Pontoise, France

Roubaix, France
Germany

Bad Nauheim, Germany

Berlin, Germany

Lambrecht, Germany
Netherlands

Ad Delft, Netherlands

Sponsors and Collaborators

Daiichi Sankyo Europe, GmbH

More Information

No publications provided

Responsible Party:	Senior Manager Clinical Development, Daiichi Sankyo Europe GmbH
ClinicalTrials.gov Identifier:	NCT00679484 History of Changes
Other Study ID Numbers:	DSE-866-45, 2007-003060-22 EUDRACT Number
Study First Received:	May 14, 2008
Last Updated:	August 6, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Candesartan cilexetil
Candesartan
Olmesartan
Olmesartan medoxomil

Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012