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Reduction of Adverse Drug Events and Readmissions (RADAR-PGX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by MD Global, Inc.
Sponsor:
Information provided by (Responsible Party):
MD Global, Inc.
ClinicalTrials.gov Identifier:
NCT02738047
First received: March 28, 2016
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.

Condition
Pharmacogenomic Testing for Medication Management

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 120 Days
Official Title: Pharmacogenomic Test Assessment for Medication Management in the Advancement of Medicine

Further study details as provided by MD Global, Inc.:

Primary Outcome Measures:
  • Radar, Pharmocogenomic [ Time Frame: The period of enrollment is anticipated to be 36 months with a 120- day follow-up period, for total study duration of approximately 40 months from first patient enrolled to completion of follow-up on the last patient in. ]

    The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each patient when:

    1. A genotype known to affect a drug the patient is taking is identified, *and*
    2. The patient's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation.

    Change in drug dose, substitution, or discontinuation among patients with an identified genotype known to affect a drug the patient is taking as directed. This will be assessed by a quantitative survey.



Estimated Enrollment: 280000
Study Start Date: March 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Detailed Description:
Pharmocogenomic. A multicenter, observational study to evaluate the use of a Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known to be influenced by genetic variation.
  Eligibility

Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who are under treatment with several drugs with any of the sequences of biochemical reactions, catalyzed by enzymes, known to be influenced by genetic variation in a patient population.
Criteria

INCLUSION CRITERIA

Patients may be included in the Study if they meet all of the following inclusion criteria:

  1. Male or female patients of 25 years of age or older who are able to give their written Informed Consent to participate in a Clinical Study based on voluntary agreement with a thorough explanation of the patient's participation will be provided to them.
  2. Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 120 days ("index PGx test assessment");
  3. Patient was receiving at least one medication known to be associated with allelic variation at the time of the ("index PGx test assessment"), including over-the- counter medications;
  4. Patient has a history of at least one TDAE over the 24-month period preceding the PGx test assessment, or has experienced inadequate efficacy from a target drug.

EXCLUSION CRITERIA

Patients will be excluded from the Study if any of the following criteria apply:

  1. Patient is currently hospitalized;
  2. Patient's medical and medication history is unavailable over the 120-day period preceding the PGx test assessment;
  3. Patient is unable to provide an accurate history due to mental Incapacity;
  4. Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02738047

Contacts
Contact: David Brewer 239-908-0413 Dave.B@Radar-PGxStudy.com
Contact: Diana M Messir 239-908-0412 Diana.M@Radar-PGxStudy.com

Locations
United States, Arizona
AKDHC Medical Research Services Recruiting
Phoenix, Arizona, United States, 85035
Contact: N. Roxanna Neyra, M.D.    602-351-3041      
Principal Investigator: N. Roxanna Neyra, M.D.         
United States, Arkansas
NEA Baptist Clinic Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Wallace S Hoke, M.D.    870-934-5755      
Principal Investigator: Wallace S Hoke, M.D.         
United States, California
Elk Grove Clinical Research Recruiting
Elk Grove, California, United States, 95757
Contact: Dwight Bass, M.D.    916-513-7027      
Principal Investigator: Dwight Bass, M.D.         
United States, Colorado
Mesa Behavioral Clinic Recruiting
Grand Junction, Colorado, United States, 81506
Contact: Robert Sammons, M.D., Phd    970-242-6135      
Principal Investigator: Robert Sammons, M.D., Phd         
United States, Florida
South Florida Medical Research Recruiting
Aventura, Florida, United States, 33180
Contact: Marc C Gittleman, M.D.    305-931-8080      
Principal Investigator: Marc C Gittleman, M.D.         
Advance Medical Research Service Corp. Recruiting
Miami, Florida, United States, 33165
Principal Investigator: Blas E. Prieto, MD         
ITB Research Recruiting
Miami, Florida, United States, 33182
Contact: Vivianne Zerquera    305-274-4351    vzerquera.itb@gmail.com   
Principal Investigator: Gregory Alfred, M.D.         
NeuroMedical Research Institute Recruiting
Panama City, Florida, United States, 32405
Contact: Cassi Hiers    850-215-7093      
Contact: Beth Golden    8502157093      
Principal Investigator: George Barrio, MD         
United States, Georgia
Clinical Research Institute Recruiting
Stockbridge, Georgia, United States, 30281
Contact: Beverley Jenkins    770-507-8344      
Principal Investigator: Phillip Nowlin, MD         
United States, Ohio
Florea Buckeye Health & Research Recruiting
Columbus, Ohio, United States, 43207
Contact: Robert Florea, M.D.    614-850-7450      
Principal Investigator: Robert Florea, M.D.         
United States, South Carolina
Palmetto Research Center, LLC Recruiting
Spartanburg, South Carolina, United States, 29302
Contact: Ronald H Littlefield, M.D.    864-582-6202      
Principal Investigator: Ronald H Littlefield, M.D.         
Sponsors and Collaborators
MD Global, Inc.
Investigators
Principal Investigator: Louis Rosenfield, MD Cardiac Services Associates
Study Director: Michael Cohen, PHD Clinical Research for Professionals
  More Information

Responsible Party: MD Global, Inc.
ClinicalTrials.gov Identifier: NCT02738047     History of Changes
Other Study ID Numbers: 10202016
Study First Received: March 28, 2016
Last Updated: February 9, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

ClinicalTrials.gov processed this record on April 27, 2017