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Sponsored by: |
Daiichi Sankyo Europe, GmbH |
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Information provided by: | Daiichi Sankyo Inc. |
ClinicalTrials.gov Identifier: | NCT00679484 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 400 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: olmesartan medoxomil + candesartan cilexetil placebo
Dosage form: tablet; frequency: daily; duration: 24 weeks
|
2: Experimental |
Drug: olmesartan medoxomil placebo + candesartan cilexetil
Dosage form: tablets; frequency: daily; duration: 24 weeks
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Faiez Zannad, MD, PhD | +33 383 65 66 25 | f.zannad@chu-nancy.fr |
Contact: Stephanie Grojean | +33 383 65 66 14 | s.grojean@chu-nancy.fr |
France | |
Recruiting | |
Cholet, France | |
Recruiting | |
Langres, France | |
Recruiting | |
Pontoise, France | |
Recruiting | |
Bron, France | |
Recruiting | |
Roubaix, France | |
Recruiting | |
Cedex, France | |
Recruiting | |
Mannheim, France | |
Germany | |
Recruiting | |
Berlin, Germany | |
Recruiting | |
Lambrecht, Germany | |
Recruiting | |
Bad Nauheim, Germany | |
Netherlands | |
Recruiting | |
Ad Delft, Netherlands |
Responsible Party: | Daiichi Sankyo Europe GmbH ( Senior Manager Clinical Development ) |
Study ID Numbers: | DSE-866-45, 2007-003060-22 EUDRACT Number |
Study First Received: | May 14, 2008 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00679484 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Candesartan cilexetil Heart Failure Heart Diseases |
Candesartan Olmesartan medoxomil Angiotensin II |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |