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

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ClinicalTrials.gov Identifier: NCT02738047
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
MD Global, Inc.

Study Description
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Brief Summary:
Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.

Condition or disease
Pharmacogenomic Testing for Medication Management

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 280000 participants
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
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
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
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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): 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, Pennsylvania
MD@Home Recruiting
York, Pennsylvania, United States, 17402
Contact: Marv Inscore    717-840-8686      
Sponsors and Collaborators
MD Global, Inc.
Investigators
Principal Investigator: Donald Mansfield, MD VAC
Study Director: Michael Cohen, PHD Clinical Research for Professionals
More Information
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Responsible Party: MD Global, Inc.
ClinicalTrials.gov Identifier: NCT02738047     History of Changes
Other Study ID Numbers: 10202016
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided