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
250000 participants
OBSERVATIONAL
2013-11-30
Brief Summary
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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 has provided written informed consent;
* Subject is taking at least three (3) regularly scheduled medications, excluding as needed (PRN) medications, over the counter medications and nutritional supplements; two (2) of which are known to be affected by genetic allelic variation.
* Subject's treating physician has a clinical suspicion that the subject is experiencing adverse signs or symptoms related to a prescribed medication or is not achieving the intended effect from the medication.
Exclusion Criteria
* Subject has a history of abnormal hepatic function within the last 2 years (INR \>1.2 not attributable to anticoagulant medications, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \>1.5x normal, or suspected cirrhosis);
* Subject has a history of malabsorption (short gut syndrome);
* Subject has a history of any gastric or small bowel surgery;
* Subject is currently hospitalized;
* Subject is currently being treated with intravenous medication;
* Subject underwent prior pharmacogenomic testing with results reported within the last 12 months.
Subjects may be eligible within 60 days from the date of pharmacogenomic testing.
18 Years
ALL
No
Sponsors
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Syntactx
NETWORK
Renaissance RX
INDUSTRY
Responsible Party
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Locations
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Edwards Lake Medical Center
Birmingham, Alabama, United States
Gerald Harris MD
Glendale, Arizona, United States
Holland Center for Family Health
Peoria, Arizona, United States
AZ Pain Center
Phoenix, Arizona, United States
Olga Voroshilovsky
Los Angeles, California, United States
Institute for Regenerative Medicine and Clinical Research
Pasadena, California, United States
Boulder Medical Center
Boulder, Colorado, United States
Prime Healthcare - Anthony Roselli MD
Avon, Connecticut, United States
Washington Pain Center
Washington D.C., District of Columbia, United States
Continental Research Network
Doral, Florida, United States
Latin Foundation for Health
Miami, Florida, United States
Primary Care Associates, P.A.
Stuart, Florida, United States
Roman Medical Group
Columbus, Georgia, United States
Wellness Medicine
Hampton, Georgia, United States
Ocmulgee Physicians
Macon, Georgia, United States
Macon Family Health Center Inc.
Macon, Georgia, United States
Your Personal Physician
Rome, Georgia, United States
Valley Health Care
Rome, Georgia, United States
Dr. B. Abraham PC
Snellville, Georgia, United States
Candler Internal Medicine
Statesboro, Georgia, United States
Primary Health Associates
Orland Park, Illinois, United States
Women's Care Center
Lexington, Kentucky, United States
Healthy Heart Cardiology
Grandville, Michigan, United States
Heart Cardiology Consultants
Southfield, Michigan, United States
Union Square Medical Associates, PC
Elizabeth, New Jersey, United States
United Medical PC
Lyndhurst, New Jersey, United States
Internal Medicine Specialists of Alamogordo, P.C.
Alamogordo, New Mexico, United States
Lovelace Rehabilitation Hospital
Albuquerque, New Mexico, United States
Sage Neuroscience Center
Albuquerque, New Mexico, United States
Geriatrics Associates, PAC
Albuquerque, New Mexico, United States
Isabel C Vigil MD
Las Cruces, New Mexico, United States
Larry F Berman MD PC
Charlotte, North Carolina, United States
Lakewood Pediatrics and Family Medicine
Durham, North Carolina, United States
Carolina Urology Partners
Gastonia, North Carolina, United States
Carolina Neurosurgery and Spine Associates
Greensboro, North Carolina, United States
Comprehensive Pain Center
Columbus, Ohio, United States
Knightsbridge Internal Medicine and Cardiology Associates, Inc
Columbus, Ohio, United States
Gateway Health and Wellness LLC
Columbus, Ohio, United States
Robert E Barkett Jr MD
Mansfield, Ohio, United States
Midwestern Internal Medicine Associates (MIMA)
Marion, Ohio, United States
Stonegate Family Health
Reynoldsburg, Ohio, United States
Primary Care Associates - Unity
Tallmadge, Ohio, United States
Easton Cardiovascular Associates
Easton, Pennsylvania, United States
Carolina Center For Advanced Management Of Pain
Greenville, South Carolina, United States
Colonial Family Practice
Sumter, South Carolina, United States
Palmetto Adult Medicine
Sumter, South Carolina, United States
Parkway Cardiology Associates
Oak Ridge, Tennessee, United States
Mark A. Sanders, DO
Fort Worth, Texas, United States
Emporia Medical Associates
Emporia, Virginia, United States
Countries
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References
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Onder G, Petrovic M, Tangiisuran B, Meinardi MC, Markito-Notenboom WP, Somers A, Rajkumar C, Bernabei R, van der Cammen TJ. Development and validation of a score to assess risk of adverse drug reactions among in-hospital patients 65 years or older: the GerontoNet ADR risk score. Arch Intern Med. 2010 Jul 12;170(13):1142-8. doi: 10.1001/archinternmed.2010.153.
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5. doi: 10.1001/jama.279.15.1200.
Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011 Nov 24;365(21):2002-12. doi: 10.1056/NEJMsa1103053.
Mallet L, Spinewine A, Huang A. The challenge of managing drug interactions in elderly people. Lancet. 2007 Jul 14;370(9582):185-191. doi: 10.1016/S0140-6736(07)61092-7.
Epstein RS, Moyer TP, Aubert RE, O Kane DJ, Xia F, Verbrugge RR, Gage BF, Teagarden JR. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study). J Am Coll Cardiol. 2010 Jun 22;55(25):2804-12. doi: 10.1016/j.jacc.2010.03.009. Epub 2010 Apr 8.
Wang L, McLeod HL, Weinshilboum RM. Genomics and drug response. N Engl J Med. 2011 Mar 24;364(12):1144-53. doi: 10.1056/NEJMra1010600. No abstract available.
Aronson JK. Adverse drug reactions--no farewell to harms. Br J Clin Pharmacol. 2007 Feb;63(2):131-5. doi: 10.1111/j.1365-2125.2006.02860.x. No abstract available.
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9. doi: 10.1016/S0140-6736(00)02799-9.
Gage BF, Eby C, Johnson JA, Deych E, Rieder MJ, Ridker PM, Milligan PE, Grice G, Lenzini P, Rettie AE, Aquilante CL, Grosso L, Marsh S, Langaee T, Farnett LE, Voora D, Veenstra DL, Glynn RJ, Barrett A, McLeod HL. Use of pharmacogenetic and clinical factors to predict the therapeutic dose of warfarin. Clin Pharmacol Ther. 2008 Sep;84(3):326-31. doi: 10.1038/clpt.2008.10. Epub 2008 Feb 27.
International Warfarin Pharmacogenetics Consortium; Klein TE, Altman RB, Eriksson N, Gage BF, Kimmel SE, Lee MT, Limdi NA, Page D, Roden DM, Wagner MJ, Caldwell MD, Johnson JA. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med. 2009 Feb 19;360(8):753-64. doi: 10.1056/NEJMoa0809329.
Garcia DA, Lopes RD, Hylek EM. New-onset atrial fibrillation and warfarin initiation: high risk periods and implications for new antithrombotic drugs. Thromb Haemost. 2010 Dec;104(6):1099-105. doi: 10.1160/TH10-07-0491. Epub 2010 Sep 30.
Meckley LM, Gudgeon JM, Anderson JL, Williams MS, Veenstra DL. A policy model to evaluate the benefits, risks and costs of warfarin pharmacogenomic testing. Pharmacoeconomics. 2010;28(1):61-74. doi: 10.2165/11318240-000000000-00000.
Relling MV, Klein TE. CPIC: Clinical Pharmacogenetics Implementation Consortium of the Pharmacogenomics Research Network. Clin Pharmacol Ther. 2011 Mar;89(3):464-7. doi: 10.1038/clpt.2010.279. Epub 2011 Jan 26.
Gandhi TK, Weingart SN, Borus J, Seger AC, Peterson J, Burdick E, Seger DL, Shu K, Federico F, Leape LL, Bates DW. Adverse drug events in ambulatory care. N Engl J Med. 2003 Apr 17;348(16):1556-64. doi: 10.1056/NEJMsa020703.
Huhtakangas J, Tetri S, Juvela S, Saloheimo P, Bode MK, Hillbom M. Effect of increased warfarin use on warfarin-related cerebral hemorrhage: a longitudinal population-based study. Stroke. 2011 Sep;42(9):2431-5. doi: 10.1161/STROKEAHA.111.615260. Epub 2011 Jul 28.
Other Identifiers
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2013-101
Identifier Type: -
Identifier Source: org_study_id
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