Utility of PharmacoGenomics for Reducing Adverse Drug Effects (UPGRADE)
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|ClinicalTrials.gov Identifier: NCT02081872|
Recruitment Status : Unknown
Verified September 2015 by Companion Dx Reference Lab, LLC.
Recruitment status was: Recruiting
First Posted : March 7, 2014
Last Update Posted : October 8, 2015
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."
|Condition or disease|
|Genetics of Drug Metabolism|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||279000 participants|
|Target Follow-Up Duration:||90 Days|
|Official Title:||Utility of PharmacoGenomics for Reducing Adverse Drug Effects|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
- Occurrence of Meaningful Change in Drug Regimen [ Time Frame: 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.
- 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 [ Time Frame: 90 days ]
- 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 [ Time Frame: 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. [ Time Frame: 90 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081872
|Contact: Study Coordinatorfirstname.lastname@example.org|
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