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)

This study has been terminated.
(Lack of subject recruitment)
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00679484
First received: May 14, 2008
Last updated: August 6, 2010
Last verified: August 2010
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014