Utility of PharmacoGenomics for Reducing Adverse Drug Effects

• Conditions: Genetics of Drug Metabolism

• Registration Number: NCT02081872
• Lead Sponsor: Companion Dx Reference Lab, LLC

Brief Summary

UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug reactions, hospitalizations and emergency department visits.

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."

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-07
• Study Start: 2014-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-08
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 279000

Inclusion Criteria

• Subject plans to undergo current index PGx testing at the time of enrollment or underwent current index PGx testing within the prior 1-year period, for genes known to influence metabolism of at least one target drug
• 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 is currently hospitalized
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of Meaningful Change in Drug Regimen	90 Days	The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined for each subject as: * A genotype known to affect a target drug is identified by PGx testing, AND; * The treating physician makes at least one target drug regimen change in dose, frequency, or route of administration, or when target drug discontinuation or substitutions occur.

Secondary Outcome Measures

Name	Time	Method
Number of Target Drug-Related Adverse events (TDAE) over the 90-day period preceding receipt of PGx test results compared with the number over the 90-day period after the test	90 days
Target-drug related outpatient clinic visits, emergency department visits, and hospitalizations over the 90-day period prior to the receipt of PGx test results, compared to the number of visits over the 90-day period following testing.	90 Days
Changes in target drug regimen over the 90-day period preceding receipt of PGx results, compared to the changes made in the 90-day period thereafter	90 days

Trial Locations

Locations (38)

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

Angel E. Rico, M.D. PA; 🇺🇸 Miami Lakes, Florida, United States

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