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:
Daiichi Sankyo Europe, GmbH
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00679484
First received: May 14, 2008
Last updated: August 6, 2010
Last verified: August 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 medoxomil Olmesartan |
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 May 19, 2013