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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)

Primary Purpose

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

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
olmesartan medoxomil + candesartan cilexetil placebo
olmesartan medoxomil placebo + candesartan cilexetil
Sponsored by
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 If a female becomes pregnant during the study, she has to be withdrawn immediately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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Absolute BNP change from week 0 to 24 of treatment

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)
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

Full Information

First Posted
May 14, 2008
Last Updated
December 20, 2018
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
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1. Study Identification

Unique Protocol Identification Number
NCT00679484
Brief Title
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
Acronym
OLMEBNP
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 Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Why Stopped
Lack of subject recruitment
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil + candesartan cilexetil placebo
Intervention Description
Dosage form: tablet; frequency: daily; duration: 24 weeks
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil placebo + candesartan cilexetil
Intervention Description
Dosage form: tablets; frequency: daily; duration: 24 weeks
Primary Outcome Measure Information:
Title
Absolute BNP change from week 0 to 24 of treatment
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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
Title
BNP change from week 0 to week 4, 8, and 16
Time Frame
16 weeks maximum
Title
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
Title
Event-free survival
Time Frame
24 weeks
Title
Time-to-death
Time Frame
24 weeks
Title
Time-to-first cardiovascular event
Time Frame
24 weeks maximum
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
City
Bron
Country
France
City
Cedex
Country
France
City
Cholet
Country
France
City
Langres
Country
France
City
Mannheim
Country
France
City
Pontoise
Country
France
City
Roubaix
Country
France
City
Bad Nauheim
Country
Germany
City
Berlin
Country
Germany
City
Lambrecht
Country
Germany
City
Ad Delft
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. 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: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/

Learn more about this trial

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

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