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NCT Number: NCT02738047

Reduction of Adverse Drug Events and Readmissions

Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.

Recruiting

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MD@Home

York, Pennsylvania, 17402, United States

Location status: Recruiting

Location contact

Marv Inscore

CONTACT

717-840-8686

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • 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.
  • Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 120 days ("index PGx test assessment");
  • 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;
  • 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:

  • Patient is currently hospitalized;
  • Patient's medical and medication history is unavailable over the 120-day period preceding the PGx test assessment;
  • Patient is unable to provide an accurate history due to mental Incapacity;
  • 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.

Treatment and study plan

Primary outcomes

  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:

    • A genotype known to affect a drug the patient is taking is identified, *and*
    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana M Messir

CONTACT

[email protected]

239-908-0412

Diana Messir

CONTACT

[email protected]

239-908-0412

Sponsors and collaborators

Lead sponsor

ClinLogic LLC

Industry

Registry information

Official study title

Pharmacogenomic Test Assessment for Medication Management in the Advancement of Medicine

Acronym: RADAR-PGX

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Apr 14, 2016
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.