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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
Sponsor:
Information provided by (Responsible Party):
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."


Condition or disease
Genetics of Drug Metabolism

Study Type : Observational [Patient Registry]
Estimated Enrollment : 279000 participants
Observational Model: Cohort
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects over the age of 18, receiving at least one medication with metabolism known to depend on genetic allelic variation.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Study Coordinator upgrade@companiondxlab.com

  Show 41 Study Locations
Sponsors and Collaborators
Companion Dx Reference Lab, LLC

Responsible Party: Companion Dx Reference Lab, LLC
ClinicalTrials.gov Identifier: NCT02081872     History of Changes
Other Study ID Numbers: 2013-101
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: September 2015

Keywords provided by Companion Dx Reference Lab, LLC:
Pharmacogenomics
Target Drug Related Adverse Events (TDAE)

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders