Utility of PharmacoGenomics for Reducing Adverse Drug Effects
NCT ID: NCT02081872
Last Updated: 2015-10-08
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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UNKNOWN
279000 participants
OBSERVATIONAL
2014-04-30
2017-07-31
Brief Summary
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The way an individual processes a drug is in part determined by their genes, and there is known to be genetic variation between humans in the way drugs are metabolized. The study of the way genes affect a person's response to drugs is known as "Pharmacogenomics."
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Detailed Description
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Conditions
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Study Design
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COHORT
Eligibility Criteria
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Inclusion Criteria
* Subject is aged ≥18 years
* Subject is able and willing to provide written informed consent
* Subject reveals a history of at least one TDAE or an inadequate therapeutic effect from a target drug over the 12-month period preceding expected receipt of PGx test results
* Subject is not taking an investigational medication or in an interventional trial that would interfere with participation in the registry
Exclusion Criteria
* Subject's medical and medication history is unavailable over the 90-day periods preceding and following the receipt of pharmacogenomic test results
* Subject is unable to provide an accurate history due to mental incapacity
* Subject is known to have undergone prior pharmacogenomic testing (exclusive of the current index PGx testing) for genes specific to the target drugs within the 2-year period preceding enrollment and these results have been previously evaluated
18 Years
ALL
No
Sponsors
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Companion Dx Reference Lab, LLC
INDUSTRY
Responsible Party
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Locations
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Scottsdale Cardiovascular Center
Scottsdale, Arizona, United States
ARcare
Augusta, Arkansas, United States
Retina Institute of California
Arcadia, California, United States
John Allen, M.D.
El Cajon, California, United States
Delaware Electrophysiology & Cardiology
Newark, Delaware, United States
Boca Raton Clinical Research
Boca Raton, Florida, United States
St. Francis Sleep, Allergy & Lung Institute
Clearwater, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Israel Machin M.D., PA
Lake Clarke Shores, Florida, United States
Shaw Research Specialists, Inc.
Miami, Florida, United States
Angel E. Rico, M.D. PA
Miami Lakes, Florida, United States
Advanced Behavioral Care, LLC
Palm Bay, Florida, United States
Diverse Clinical Research Center of Chicago, LLC
Chicago, Illinois, United States
Aida Mihajlovic M.D. Inc.
Olympia Fields, Illinois, United States
Northshore Allergy & Immunology, LLC
Covington, Louisiana, United States
Centex Studies Inc
Lake Charles, Louisiana, United States
B. John Hynes, M.D.
Elkton, Maryland, United States
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States
Pain Medicine Physicians
Millburn, New Jersey, United States
Vanguard Medical Group
Montville, New Jersey, United States
Virtua Medical Group, P.A.
Moorestown, New Jersey, United States
Coventry Cardiology Associates
Phillipsburg, New Jersey, United States
Pennington Infectious Disease Associates
Trenton, New Jersey, United States
White Oak Family Physicians, PA
Asheboro, North Carolina, United States
Allergy Partners, P.A.
Asheville, North Carolina, United States
Buckeye Health and Research LLC
Hilliard, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Family Medicine and Occupational Health, Inc
Shaker Heights, Ohio, United States
Lehigh Valley Hospital's Network Office of Research and innovation
Allentown, Pennsylvania, United States
Wound Institute & Research Center
Dunmore, Pennsylvania, United States
Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States
Wellmon Family Practice
Shippensburg, Pennsylvania, United States
Abington Neurological Associates, LTD.
Willow Grove, Pennsylvania, United States
Austin, Texas, United States
Harlingen, Texas, United States
South Shore Medical Center
League City, Texas, United States
Renaissance Psychiatry
McAllen, Texas, United States
Centex Studies Inc
Pharr, Texas, United States
Hillcrest Family Health Center
Waco, Texas, United States
Millennium Clinical Trials LLC
Arlington, Virginia, United States
Ettrick Health Center, LLC
South Chesterfield, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Krishnaswami Vijayaraghaven, M.D.
Role: primary
Jaime Whitehead, FNP-BC
Role: primary
Michael Samuel, MD
Role: primary
John W. Allen, M.D.
Role: primary
Joseph C Pennington, MD
Role: primary
Gina Vendetti, MD
Role: primary
Francis Averill, M.D.
Role: primary
Khalil Afsh, M.D.
Role: primary
Israel Machin, M.D.
Role: primary
Andrew Basile, DO
Role: primary
Angel E Rico, M.D.
Role: primary
Richard Bunt, M.D.
Role: primary
Thomas L Pitts, M.D.
Role: primary
Aida Mihajlovic, M.D.
Role: primary
Richard J. Guillot, M.D.
Role: primary
Michael Seep, MD
Role: primary
Walter Duffy, MD
Role: primary
Giovanni Ramundo, MD
Role: primary
Andrew Gilmartin, MD
Role: primary
Thomas Galski, D.O.
Role: primary
Daniel Mascarenhas, M.D.
Role: primary
Marc S Whitman, MD
Role: primary
Robert Scott, M.D.
Role: primary
Frank J Lichtenberger, MD
Role: primary
Robert Florea, M.D.
Role: primary
Franklin Handel, M.D.
Role: primary
Elizabeth Ranasinghe, MD
Role: primary
John A Mannisi
Role: primary
Michael Moore, M.D.
Role: primary
Megha Manek, MD
Role: primary
Baxter D Wellmon, DO
Role: primary
David Weisman, M.D.
Role: primary
Michael Rotman, MD
Role: primary
Jack Janoe, MD
Role: primary
Jose Igoa, M.D.
Role: primary
Hiram Garcia, MD
Role: primary
Allison Crawford, M.D.
Role: primary
Maria B Natividad, MD
Role: primary
Loknath Shandilya, M.D.
Role: primary
Other Identifiers
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2013-101
Identifier Type: -
Identifier Source: org_study_id
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