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Sponsored by: |
Synvista Therapeutics, Inc |
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Information provided by: | Synvista Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT00662116 |
This study is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. The primary assessment for effectiveness is the assessment of exercise tolerance.
Condition | Intervention | Phase |
---|---|---|
Diastolic Heart Failure |
Drug: alagebrium Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure |
Estimated Enrollment: | 160 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: alagebrium
200 mg (two 100 mg tablets) two times daily for 24 weeks
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2: Placebo Comparator |
Drug: placebo
placebo tablets - two tablets taken twice daily
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Bertram Pitt, MD | University of Michigan |
Responsible Party: | Synvista ( Carl Mendel, MD/Chief Medical Officer ) |
Study ID Numbers: | ALT-711-0530 |
Study First Received: | April 17, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00662116 History of Changes |
Health Authority: | United States: Food and Drug Administration |
diastolic heart failure |
Heart Failure, Diastolic Heart Failure Heart Diseases |
Heart Failure, Diastolic Heart Failure Heart Diseases Cardiovascular Diseases |