A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
NCT ID: NCT00863707
Last Updated: 2012-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
511 participants
INTERVENTIONAL
2009-04-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Placebo
Matching intravenous (IV) bolus injection
Placebo
IV
Regadenoson
0.4 mg/5 mL intravenous bolus injection
Regadenoson
IV
Interventions
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Regadenoson
IV
Placebo
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has a diagnosis of Coronary Artery Disease (CAD) or risk factors for CAD as determined by a current medical diagnosis of at least 2 of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity (Body Mass Index (BMI) \> 30)
* Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration
* Subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson
Exclusion Criteria
* Female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the Follow-Up visit is complete
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Anniston, Alabama, United States
Little Rock, Arkansas, United States
Bell Gardens, California, United States
Fullerton, California, United States
Garden Grove, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Oakland, California, United States
Roseville, California, United States
Santa Ana, California, United States
Newark, Delaware, United States
Wilmington, Delaware, United States
Fort Lauderdale, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Trinity, Florida, United States
Winter Park, Florida, United States
Ellijay, Georgia, United States
Chicago, Illinois, United States
Auburn, Maine, United States
Detroit, Michigan, United States
Flint, Michigan, United States
Minneapolis, Minnesota, United States
Ridgewood, New Jersey, United States
Somerset, New Jersey, United States
New York, New York, United States
Springfield Gardens, New York, United States
Springfield, Ohio, United States
Oklahoma City, Oklahoma, United States
Bend, Oregon, United States
Duncansville, Pennsylvania, United States
Indiana, Pennsylvania, United States
Tyrone, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Spartanburg, South Carolina, United States
Knoxville, Tennessee, United States
Houston, Texas, United States
Houston, Texas, United States
Sugar Grove, Texas, United States
Countries
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References
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Ananthasubramaniam K, Weiss R, McNutt B, Klauke B, Feaheny K, Bukofzer S. A randomized, double-blind, placebo-controlled study of the safety and tolerance of regadenoson in subjects with stage 3 or 4 chronic kidney disease. J Nucl Cardiol. 2012 Apr;19(2):319-29. doi: 10.1007/s12350-011-9508-3. Epub 2012 Jan 19.
Related Links
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Link to Prescribing Information
Other Identifiers
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3606-CL-3010
Identifier Type: -
Identifier Source: org_study_id
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