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Sponsored by: |
Synvista Therapeutics, Inc |
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Information provided by: | Synvista Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT00739687 |
Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a role in the development and progression of heart failure. The AGE-crosslink breaker Alagebrium improved cardiac function and symptoms in experimental preclinical and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial. Objective: to evaluate the safety and efficacy of alagebrium in subjects diagnosed with heart failure. This is a randomized, double-blind, placebo-controlled trial to assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100 subjects will be studied (50 per treatment group) in approximately 6 centers. Procedures: exercise testing (VO2 max; the primary variable), ECGs and blood sampling.
Condition | Intervention | Phase |
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Chronic Heart Failure |
Drug: ALT-711 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure |
Estimated Enrollment: | 100 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
ALT-711: Experimental
Alagebrium 200 mg BID
|
Drug: ALT-711
200 mg tablet BID for 9 months.
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Placebo: Experimental
Placebo
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Drug: Placebo
200 mg tablet BID for 9 months.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama Hospital | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Robert C. Bourge, M.D. 205-934-3438 | |
Sub-Investigator: Barry K. Rayburn, M.D. | |
United States, Michigan | |
Henry Ford Hospital | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: David Lanfear, M.D. 313-972-1920 | |
United States, North Carolina | |
Wake Forest University Health Sciences | Recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Dalane W. Kitzman, M.D. 336-716-3274 | |
United States, South Carolina | |
Medical University of South Carolina (MUSC) | Recruiting |
Charleston, South Carolina, United States, 29403 | |
Contact: Adrian Van Bakel, MD 843-876-4790 | |
Principal Investigator: Adrian Van Bakel, MD |
Responsible Party: | University Medical Center Groningen, Groningen, The Netherlands ( Adriaan A. Voors, MD, PhD ) |
Study ID Numbers: | ALT-711-0527a |
Study First Received: | August 21, 2008 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00739687 |
Health Authority: | United States: Food and Drug Administration |
Chronic Heart Failure |
Heart Failure Heart Diseases |
Cardiovascular Diseases |