Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)
NCT ID: NCT00662116
Last Updated: 2009-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
160 participants
INTERVENTIONAL
2008-03-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
alagebrium
200 mg (two 100 mg tablets) two times daily for 24 weeks
2
placebo
placebo tablets - two tablets taken twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
alagebrium
200 mg (two 100 mg tablets) two times daily for 24 weeks
placebo
placebo tablets - two tablets taken twice daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* EF \>/= 45% via echo within 1 year and evidence of diastolic heart failure via echo measurement of E/E'\>/= 12 determined by echo within 1 year
* previous hospitalization for heart failure or previous BNP \>100 pg/mL.
Exclusion Criteria
* history of stroke/TIA or reversible ischemic neurological defect w/i 6 mths
* history of acute MI within 6 months
* severe COPD
* active or treated malignancies (except basal cell carcinoma)
* significant systemic illnesses that would prohibit completion of the study or compliance
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Synvista Therapeutics, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Synvista
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bertram Pitt, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Anaheim, California, United States
Bakersfield, California, United States
La Jolla, California, United States
Roseville, California, United States
Jacksonville, Florida, United States
Miami, Florida, United States
St. Petersburg, Florida, United States
Covington, Georgia, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Auburn, Maine, United States
South Portland, Maine, United States
Ayer, Massachusetts, United States
Lincoln, Nebraska, United States
Ridgewood, New Jersey, United States
Albany, New York, United States
Stony Brook, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Fairfield, Ohio, United States
Sandusky, Ohio, United States
Oklahoma City, Oklahoma, United States
Charleston, South Carolina, United States
Germantown, Tennessee, United States
Lackland Airforce Base, Texas, United States
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ALT-711-0530
Identifier Type: -
Identifier Source: org_study_id