Pharmacogenomics Registry to Assess Clinical Utility (PREACT)
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|ClinicalTrials.gov Identifier: NCT02374840|
Recruitment Status : Unknown
Verified July 2015 by Companion Dx Reference Lab, LLC.
Recruitment status was: Not yet recruiting
First Posted : March 2, 2015
Last Update Posted : July 22, 2015
The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help healthcare providers manage patient medication regimens and assess if the testing has an effect on reducing medication side effects, 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|
|Drug Side Effects|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||340778 participants|
|Target Follow-Up Duration:||90 Days|
|Official Title:||Pharmacogenomics Registry to Assess Clinical Utility|
|Estimated Primary Completion Date :||February 2019|
- Meaningful Change [ Time Frame: 90 day ]
Binary occurrence of meaningful change in drug regimen, defined for each subject as:
- A genotype known to affect a target drug is identified by pharmacogenomic testing, and
- The treating physician makes at least one target drug regimen change in dose, frequency, route of administration, drug discontinuation, addition or substitution.
- Changes in target drug regimen [ Time Frame: 90 days retrospective; 90 days prospective ]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.
- Number of target drug adverse events (TDAE) [ Time Frame: 90 day retrospective; 90 day prospective ]Number of TDAE over the 90-day period preceding receipt of pharmacogenomics test results compared with the number over the 90-day period after the test
- Target drug related emergency department visits [ Time Frame: 90 day retrospective; 90 day prospective ]Emergency department visits over the 90-day period prior to receipt of pharmacogenomics test results, compared to the number of visits over the 90-day period following receipt of test results.
- Target drug related hospitalizations [ Time Frame: 90 day retrospective; 90 day prospective ]Hospitalizations over the 90-day period prior to receipt of pharmacogenomics test results, compared to the number of visits over the 90-day period following receipt of test results.
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): NCT02374840
|Contact: Study Coordinatoremail@example.com|