Pharmacogenomics Registry to Assess Clinical Utility
PREACT
1 other identifier
observational
340,778
0 countries
N/A
Brief Summary
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."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedJuly 22, 2015
July 1, 2015
February 24, 2015
July 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Meaningful Change
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.
90 day
Secondary Outcomes (4)
Changes in target drug regimen
90 days retrospective; 90 days prospective
Number of target drug adverse events (TDAE)
90 day retrospective; 90 day prospective
Target drug related emergency department visits
90 day retrospective; 90 day prospective
Target drug related hospitalizations
90 day retrospective; 90 day prospective
Eligibility Criteria
Male and female subjects aged 2 years and above, currently receiving or under consideration to receive at least one medication known to be metabolized through relevant genetically-modified pathways.
You may qualify if:
- Pharmacogenomic testing has been performed within 12-months prior to eligibility assessment for genes known to influence metabolism of at least one target drug
- Subject is 2 years of age or older
- Subject is not taking an investigational medication or in a clinical trial that would interfere with participation in the registry
You may not qualify if:
- Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of pharmacogenomic test results
- Subject (or subject's parent/guardian) is unable to provide an accurate history due to mental incapacity, in the Investigator's opinion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Target Duration
- 90 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2015
First Posted
March 2, 2015
Primary Completion
February 1, 2019
Last Updated
July 22, 2015
Record last verified: 2015-07