Evaluation of ALT-2074 in Subjects With Type-2 Diabetes, Haptoglobin Type 2-2 Genotype and Coronary Artery Disease
NCT ID: NCT00491543
Last Updated: 2008-07-02
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
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2007-06-30
2008-05-31
Brief Summary
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The purpose of this study is to assess the safety, the pharmacokinetic profile and characterize the effect on biomarkers of inflammation and oxidative stress of repeat doses of ALT 2074. Subjects must be diabetic, with evidence of coronary artery disease and a haptoglobin 2-2 genotype
Detailed Description
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Subjects who qualify will receive active drug (ALT-2074 20 mg, 40 mg or 80 mg) or placebo every 8 hours for 28 days. There will be three sequential cohorts of increasing doses of active drug. There will be 2 follow-up visits (Days 35 and 42). Blood and urine tests for safety (chemistry and hematology), pharmacokinetics and relevant biomarkers to measure inflammation and oxidative stress will be performed throughout the study. Electrocardiograms and 24-hour Holter monitoring will also be performed at various time points during the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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ALT-2074
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Type 2 diabetes mellitus
3. Stable coronary artery disease (CAD) documented or suspected, not requiring adjustment for ≥2 months, as determined by: a. A history of myocardial infarction verified by Q-wave electrocardiogram and/or medical records, occurring greater than 6 months before the screening Visit; OR b. A coronary angiogram and/or stress test; OR c. A ankle brachial pressure index less than 0.9; OR d. Age greater than 60 years of age
4. Hp 2-2 genotype.
5. Ability to communicate and comply with all study requirements.
\-
18 Years
75 Years
ALL
No
Sponsors
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Synvista Therapeutics, Inc
INDUSTRY
Principal Investigators
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Jeffrey G Geohas, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Research
Michale Noss, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Reasearch
Locations
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Radiant Research
Chicago, Illinois, United States
Radiant Research
Cincinnati, Ohio, United States
Countries
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References
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Blum S, Asaf R, Guetta J, Miller-Lotan R, Asleh R, Kremer R, Levy NS, Berger FG, Aronson D, Fu X, Zhang R, Hazen SL, Levy AP. Haptoglobin genotype determines myocardial infarct size in diabetic mice. J Am Coll Cardiol. 2007 Jan 2;49(1):82-7. doi: 10.1016/j.jacc.2006.08.044. Epub 2006 Dec 13.
Other Identifiers
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ALT-2074-201
Identifier Type: -
Identifier Source: org_study_id