Utility of PharmacoGenomics for Reducing Adverse Drug Effects (UPGRADE)

October 7, 2015 updated by: Companion Dx Reference Lab, LLC

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."

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

279000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Recruiting
        • Scottsdale Cardiovascular Center
        • Contact:
          • Krishnaswami Vijayaraghaven, M.D.
          • Phone Number: 480-945-3535
    • Arkansas
      • Augusta, Arkansas, United States, 72006
        • Recruiting
        • ARcare
        • Contact:
          • Jaime Whitehead, FNP-BC
          • Phone Number: 870-347-3402
    • California
      • Arcadia, California, United States, 91007
        • Recruiting
        • Retina Institute of California
        • Contact:
          • Michael Samuel, MD
          • Phone Number: 626-574-0188
      • El Cajon, California, United States, 92020
        • Recruiting
        • John Allen, M.D.
        • Contact:
          • John W. Allen, M.D.
          • Phone Number: 619-993-3835
    • Delaware
      • Newark, Delaware, United States, 19711
        • Recruiting
        • Delaware Electrophysiology & Cardiology
        • Contact:
          • Joseph C Pennington, MD
          • Phone Number: 302-762-3585
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Recruiting
        • Boca Raton Clinical Research
        • Contact:
          • Gina Vendetti, MD
          • Phone Number: 561-447-0614
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • St. Francis Sleep, Allergy & Lung Institute
        • Contact:
          • Francis Averill, M.D.
          • Phone Number: 727-447-3000
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • First Coast Cardiovascular Institute
        • Contact:
          • Khalil Afsh, M.D.
          • Phone Number: 904-493-3333
      • Lake Clarke Shores, Florida, United States, 33406
        • Recruiting
        • Israel Machin M.D., PA
        • Contact:
          • Israel Machin, M.D.
          • Phone Number: 561-290-5607
      • Miami, Florida, United States, 33137
        • Recruiting
        • Shaw Research Specialists, Inc.
        • Contact:
          • Andrew Basile, DO
          • Phone Number: 305-526-5505
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Angel E. Rico, M.D. PA
        • Contact:
          • Angel E Rico, M.D.
          • Phone Number: 305-495-3192
      • Palm Bay, Florida, United States, 32905
        • Recruiting
        • Advanced Behavioral Care, LLC
        • Contact:
          • Richard Bunt, M.D.
          • Phone Number: 321-622-3222
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Diverse Clinical Research Center of Chicago, LLC
        • Contact:
          • Thomas L Pitts, M.D.
          • Phone Number: 312-763-2211
      • Olympia Fields, Illinois, United States, 60461
        • Recruiting
        • Aida Mihajlovic M.D. Inc.
        • Contact:
          • Aida Mihajlovic, M.D.
          • Phone Number: 708-481-8290
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Northshore Allergy & Immunology, LLC
        • Contact:
          • Richard J. Guillot, M.D.
          • Phone Number: 985-892-3122
      • Lake Charles, Louisiana, United States, 70601
        • Recruiting
        • Centex Studies Inc
        • Contact:
          • Michael Seep, MD
          • Phone Number: 337-292-0885
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Completed
        • B. John Hynes, M.D.
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • Premier Psychiatric Research Institute, LLC
        • Contact:
          • Walter Duffy, MD
          • Phone Number: 402-817-2235
    • New Jersey
      • Millburn, New Jersey, United States, 07041
        • Recruiting
        • Pain Medicine Physicians
        • Contact:
          • Giovanni Ramundo, MD
          • Phone Number: 973-467-1466
      • Montville, New Jersey, United States, 07045
        • Recruiting
        • Vanguard Medical Group
        • Contact:
          • Andrew Gilmartin, MD
          • Phone Number: 973-575-5540
      • Moorestown, New Jersey, United States, 08057
        • Recruiting
        • Virtua Medical Group, P.A.
        • Contact:
          • Thomas Galski, D.O.
          • Phone Number: 856-786-7144
      • Phillipsburg, New Jersey, United States, 08865
        • Recruiting
        • Coventry Cardiology Associates
        • Contact:
          • Daniel Mascarenhas, M.D.
          • Phone Number: 908-859-3800
      • Trenton, New Jersey, United States, 08638
        • Recruiting
        • Pennington Infectious Disease Associates
        • Contact:
          • Marc S Whitman, MD
          • Phone Number: 609-815-7773
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Recruiting
        • White Oak Family Physicians, PA
        • Contact:
          • Robert Scott, M.D.
          • Phone Number: 336-625-1360
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Allergy Partners, P.A.
        • Contact:
          • Frank J Lichtenberger, MD
          • Phone Number: 704-873-5055
    • Ohio
      • Hilliard, Ohio, United States, 43026
        • Recruiting
        • Buckeye Health and Research LLC
        • Contact:
          • Robert Florea, M.D.
          • Phone Number: 614-850-7450
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Medical Center
        • Contact:
          • Franklin Handel, M.D.
          • Phone Number: 937-643-9939
      • Shaker Heights, Ohio, United States, 44120
        • Recruiting
        • Family Medicine and Occupational Health, Inc
        • Contact:
          • Elizabeth Ranasinghe, MD
          • Phone Number: 216-295-8400
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18101
        • Recruiting
        • Lehigh Valley Hospital's Network Office of Research and innovation
        • Contact:
          • John A Mannisi
          • Phone Number: 484-884-4799
      • Dunmore, Pennsylvania, United States, 18512
        • Recruiting
        • Wound Institute & Research Center
        • Contact:
          • Michael Moore, M.D.
          • Phone Number: 570-961-8000
      • Sayre, Pennsylvania, United States, 18840
        • Recruiting
        • Guthrie Foundation for Education and Research
        • Contact:
          • Megha Manek, MD
          • Phone Number: 570-887-2239
      • Shippensburg, Pennsylvania, United States, 17257
        • Recruiting
        • Wellmon Family Practice
        • Contact:
          • Baxter D Wellmon, DO
          • Phone Number: 717-532-3211
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Abington Neurological Associates, Ltd.
        • Contact:
          • David Weisman, M.D.
          • Phone Number: 215-957-9250
    • Texas
      • Austin, Texas, United States, 78735
        • Recruiting
        • Contact:
          • Michael Rotman, MD
          • Phone Number: 512-328-4253
      • Harlingen, Texas, United States, 78550
        • Withdrawn
      • League City, Texas, United States, 77573
        • Recruiting
        • South Shore Medical Center
        • Contact:
          • Jack Janoe, MD
          • Phone Number: 281-334-2826
      • McAllen, Texas, United States, 78501
        • Recruiting
        • Renaissance Psychiatry
        • Contact:
          • Jose Igoa, M.D.
          • Phone Number: 956-682-4401
      • Pharr, Texas, United States, 78577
        • Recruiting
        • Centex Studies Inc
        • Contact:
          • Hiram Garcia, MD
          • Phone Number: 956-342-2626
      • Waco, Texas, United States, 76710
        • Recruiting
        • Hillcrest Family Health Center
        • Contact:
          • Allison Crawford, M.D.
          • Phone Number: 254-202-3825
    • Virginia
      • Arlington, Virginia, United States, 22203
        • Recruiting
        • Millennium Clinical Trials LLC
        • Contact:
          • Maria B Natividad, MD
          • Phone Number: 703-527-8100
      • South Chesterfield, Virginia, United States, 23803
        • Recruiting
        • Ettrick Health Center, LLC
        • Contact:
          • Loknath Shandilya, M.D.
          • Phone Number: 804-526-3500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Companion Dx Reference Lab, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Genetics of Drug Metabolism

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe