Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)
NCT00662116 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2009-01-30
Summary
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.
Conditions
- Diastolic Heart Failure
Interventions
- DRUG
-
alagebrium
200 mg (two 100 mg tablets) two times daily for 24 weeks
- DRUG
-
placebo tablets - two tablets taken twice daily
Sponsors & Collaborators
-
Synvista Therapeutics, Inc
lead INDUSTRY
Principal Investigators
-
Bertram Pitt, MD · University of Michigan
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2009-10-31
- Completion
- 2009-12-31
Countries
- United States
Study Locations
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