Recruiting

PharmacoGenomicsUtility of PharmacoGenomics for Reducing Adverse Drug Effects

Sponsor:

Companion Dx Reference Lab, LLC

Code:

NCT02081872

Conditions

Genetics of Drug Metabolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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."

Conditions

Genetics of Drug Metabolism

Study ID

NCT02081872

Start date

Apr, 2014

Status verified date

Sep, 2015

Completion date

Jul, 2017

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

279000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Occurrence of Meaningful Change in Drug Regimen [ Time Frame: 90 Days ]

Central Contacts and Locations

Central contacts

Study Coordinator

upgrade@companiondxlab.com

Locations

Scottsdale Cardiovascular Center

Recruiting

Scottsdale, Arizona, United States, 85251

Contacts

Krishnaswami Vijayaraghaven, M.D.

480-945-3535

ARcare

Recruiting

Augusta, Arkansas, United States, 72006

Contacts

Jaime Whitehead, FNP-BC

870-347-3402

Retina Institute of California

Recruiting

Arcadia, California, United States, 91007

Contacts

Michael Samuel, MD

626-574-0188

John Allen, M.D.

Recruiting

El Cajon, California, United States, 92020

Contacts

John W. Allen, M.D.

619-993-3835

Delaware Electrophysiology & Cardiology

Recruiting

Newark, Delaware, United States, 19711

Contacts

Joseph C Pennington, MD

302-762-3585

Boca Raton Clinical Research

Recruiting

Boca Raton, Florida, United States, 33432

Contacts

Gina Vendetti, MD

561-447-0614

St. Francis Sleep, Allergy & Lung Institute

Recruiting

Clearwater, Florida, United States, 33765

Contacts

Francis Averill, M.D.

727-447-3000

First Coast Cardiovascular Institute

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Khalil Afsh, M.D.

904-493-3333

Israel Machin M.D., PA

Recruiting

Lake Clarke Shores, Florida, United States, 33406

Contacts

Israel Machin, M.D.

561-290-5607

Angel E. Rico, M.D. PA

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Angel E Rico, M.D.

305-495-3192

Shaw Research Specialists, Inc.

Recruiting

Miami, Florida, United States, 33137

Contacts

Andrew Basile, DO

305-526-5505

Advanced Behavioral Care, LLC

Recruiting

Palm Bay, Florida, United States, 32905

Contacts

Richard Bunt, M.D.

321-622-3222

Diverse Clinical Research Center of Chicago, LLC

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Thomas L Pitts, M.D.

312-763-2211

Aida Mihajlovic M.D. Inc.

Recruiting

Olympia Fields, Illinois, United States, 60461

Contacts

Aida Mihajlovic, M.D.

708-481-8290

Northshore Allergy & Immunology, LLC

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Richard J. Guillot, M.D.

985-892-3122

Centex Studies Inc

Recruiting

Lake Charles, Louisiana, United States, 70601

Contacts

Michael Seep, MD

337-292-0885

Premier Psychiatric Research Institute, LLC

Recruiting

Lincoln, Nebraska, United States, 68526

Contacts

Walter Duffy, MD

402-817-2235

Pain Medicine Physicians

Recruiting

Millburn, New Jersey, United States, 07041

Contacts

Giovanni Ramundo, MD

973-467-1466

Vanguard Medical Group

Recruiting

Montville, New Jersey, United States, 07045

Contacts

Andrew Gilmartin, MD

973-575-5540

Virtua Medical Group, P.A.

Recruiting

Moorestown, New Jersey, United States, 08057

Contacts

Thomas Galski, D.O.

856-786-7144

Coventry Cardiology Associates

Recruiting

Phillipsburg, New Jersey, United States, 08865

Contacts

Daniel Mascarenhas, M.D.

908-859-3800

Pennington Infectious Disease Associates

Recruiting

Trenton, New Jersey, United States, 08638

Contacts

Marc S Whitman, MD

609-815-7773

White Oak Family Physicians, PA

Recruiting

Asheboro, North Carolina, United States, 27203

Contacts

Robert Scott, M.D.

336-625-1360

Allergy Partners, P.A.

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Frank J Lichtenberger, MD

704-873-5055

Buckeye Health and Research LLC

Recruiting

Hilliard, Ohio, United States, 43026

Contacts

Robert Florea, M.D.

614-850-7450

Kettering Medical Center

Recruiting

Kettering, Ohio, United States, 45429

Contacts

Franklin Handel, M.D.

937-643-9939

Family Medicine and Occupational Health, Inc

Recruiting

Shaker Heights, Ohio, United States, 44120

Contacts

Elizabeth Ranasinghe, MD

216-295-8400

Lehigh Valley Hospital's Network Office of Research and innovation

Recruiting

Allentown, Pennsylvania, United States, 18101

Contacts

John A Mannisi

484-884-4799

Wound Institute & Research Center

Recruiting

Dunmore, Pennsylvania, United States, 18512

Contacts

Michael Moore, M.D.

570-961-8000

Guthrie Foundation for Education and Research

Recruiting

Sayre, Pennsylvania, United States, 18840

Contacts

Megha Manek, MD

570-887-2239

Wellmon Family Practice

Recruiting

Shippensburg, Pennsylvania, United States, 17257

Contacts

Baxter D Wellmon, DO

717-532-3211

Abington Neurological Associates, LTD.

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

David Weisman, M.D.

215-957-9250

Recruiting

Austin, Texas, United States, 78735

Contacts

Michael Rotman, MD

512-328-4253

South Shore Medical Center

Recruiting

League City, Texas, United States, 77573

Contacts

Jack Janoe, MD

281-334-2826

Renaissance Psychiatry

Recruiting

McAllen, Texas, United States, 78501

Contacts

Jose Igoa, M.D.

956-682-4401

Centex Studies Inc

Recruiting

Pharr, Texas, United States, 78577

Contacts

Hiram Garcia, MD

956-342-2626

Hillcrest Family Health Center

Recruiting

Waco, Texas, United States, 76710

Contacts

Allison Crawford, M.D.

254-202-3825

Millennium Clinical Trials LLC

Recruiting

Arlington, Virginia, United States, 22203

Contacts

Maria B Natividad, MD

703-527-8100

Ettrick Health Center, LLC

Recruiting

South Chesterfield, Virginia, United States, 23803

Contacts

Loknath Shandilya, M.D.

804-526-3500

More Information

Sponsor

Companion Dx Reference Lab, LLC

Last update posted

Oct 8, 2015

Last verified

Sep, 2015

Keywords

Pharmacogenomics
Target Drug Related Adverse Events (TDAE)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Companion Dx Reference Lab, LLC on 2015-10-08.