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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01970709
Other study ID # 2013-101
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 22, 2013
Last updated March 18, 2015
Start date November 2013

Study information

Verified date March 2015
Source Renaissance RX
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Observational [Patient Registry]

Clinical Trial Summary

This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and hospitalizations) associated with ADR.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 250000
Est. completion date
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject has care coordinated at the treating physician's outpatient clinic;

- 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 chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5;

- 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.

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Locations

Country Name City State
United States Internal Medicine Specialists of Alamogordo, P.C. Alamogordo New Mexico
United States Geriatrics Associates, PAC Albuquerque New Mexico
United States Lovelace Rehabilitation Hospital Albuquerque New Mexico
United States Sage Neuroscience Center Albuquerque New Mexico
United States Prime Healthcare - Anthony Roselli MD Avon Connecticut
United States Edwards Lake Medical Center Birmingham Alabama
United States Boulder Medical Center Boulder Colorado
United States Larry F Berman MD PC Charlotte North Carolina
United States Comprehensive Pain Center Columbus Ohio
United States Gateway Health and Wellness LLC Columbus Ohio
United States Knightsbridge Internal Medicine and Cardiology Associates, Inc Columbus Ohio
United States Roman Medical Group Columbus Georgia
United States Continental Research Network Doral Florida
United States Lakewood Pediatrics and Family Medicine Durham North Carolina
United States Easton Cardiovascular Associates Easton Pennsylvania
United States Union Square Medical Associates, PC Elizabeth New Jersey
United States Emporia Medical Associates Emporia Virginia
United States Mark A. Sanders, DO Fort Worth Texas
United States Carolina Urology Partners Gastonia North Carolina
United States Gerald Harris MD Glendale Arizona
United States Healthy Heart Cardiology Grandville Michigan
United States Carolina Neurosurgery and Spine Associates Greensboro North Carolina
United States Carolina Center For Advanced Management Of Pain Greenville South Carolina
United States Wellness Medicine Hampton Georgia
United States Isabel C Vigil MD Las Cruces New Mexico
United States Women's Care Center Lexington Kentucky
United States Olga Voroshilovsky Los Angeles California
United States United Medical PC Lyndhurst New Jersey
United States Macon Family Health Center Inc. Macon Georgia
United States Ocmulgee Physicians Macon Georgia
United States Robert E Barkett Jr MD Mansfield Ohio
United States Midwestern Internal Medicine Associates (MIMA) Marion Ohio
United States Latin Foundation for Health Miami Florida
United States Parkway Cardiology Associates Oak Ridge Tennessee
United States Primary Health Associates Orland Park Illinois
United States Institute for Regenerative Medicine and Clinical Research Pasadena California
United States Holland Center for Family Health Peoria Arizona
United States AZ Pain Center Phoenix Arizona
United States Stonegate Family Health Reynoldsburg Ohio
United States Valley Health Care Rome Georgia
United States Your Personal Physician Rome Georgia
United States Dr. B. Abraham PC Snellville Georgia
United States Heart Cardiology Consultants Southfield Michigan
United States Candler Internal Medicine Statesboro Georgia
United States Primary Care Associates, P.A. Stuart Florida
United States Colonial Family Practice Sumter South Carolina
United States Palmetto Adult Medicine Sumter South Carolina
United States Primary Care Associates - Unity Tallmadge Ohio
United States Washington Pain Center Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Renaissance RX Syntactx

Country where clinical trial is conducted

United States, 

References & Publications (15)

Aronson JK. Adverse drug reactions--no farewell to harms. Br J Clin Pharmacol. 2007 Feb;63(2):131-5. — View Citation

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. — View Citation

Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000 Oct 7;356(9237):1255-9. — View Citation

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. — View Citation

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. Erratum in: Clin Pharmacol Ther. 2008 Sep;84(3):430. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: N Engl J Med. 2009 Oct 15;361(16):1613. Dosage error in article text. — View Citation

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. — View Citation

Mallet L, Spinewine A, Huang A. The challenge of managing drug interactions in elderly people. Lancet. 2007 Jul 14;370(9582):185-91. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of meaningful change in drug regimen The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when:
A genotype known to affect a drug the subject is taking is identified, and
The subject's treating physician makes at least one drug regimen change in concordance with the PharmD recommendations.
60 days No
Secondary Change in the regimen of drugs controlled by genes of interest over the 12 months prior to enrollment and change in the regimen of drugs controlled by genes of interest over the 60 days following receipt of pharmacogenetic test results. 60 days No
Secondary Number of ADR per month over the 12 months prior to enrollment and number of ADR per month over the 60 days following receipt of pharmacogenomic test results. 60 days No
Secondary Frequency of genome-based PharmD recommendations to alter drug or dose. 60 days No
Secondary Emergency department visits and hospitalizations Emergency department visits over the 12 months prior to enrollment, emergency department visits over the 60 days following receipt of test results, hospitalizations over the 12 months prior to enrollment, and hospitalizations over the 60 days following receipt of test results. 60 days No
See also
  Status Clinical Trial Phase
Recruiting NCT02095769 - Pharmacogenomic Testing Of the Elderly To Reduce Morbidity N/A
Recruiting NCT02081872 - Utility of PharmacoGenomics for Reducing Adverse Drug Effects N/A