Pharmacogenetic Testing for Medication Management.

NCT ID: NCT02559193

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-05-31

Brief Summary

The Study is a single-arm prospective trial of patients receiving at least one medication with a known association between genetics and drug metabolism. All patients will undergo genetic testing as determined by their treating physician. The specific genes tested will, in general, be based upon the drugs the patients are taking or those that the patient's treating physician is considering as potential substitutes for current medications.

Detailed Description

In this data collection only trial design, the PGx test is not a protocol-specified procedure. Rather, patients are eligible if they have undergone PGx testing within the last 90 days. Thus, PGx testing will not be performed solely for inclusion in this clinical research initiative.

Conditions

Medication Management

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

No treatment.

Data collection only trial design.

Observational study, data collection only trial.

Intervention Type: OTHER

Data collection only trial design.

Interventions

Observational study, data collection only trial.

Data collection only trial design.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 90 days ("index PGx test");

2. Male or female patients 18 years or older who have given their written Informed Consent to participate in a Clinical Study based on voluntary agreement a through explanation of the patient's participation is provided to them. Patients must have adequate reading and writing abilities such that they can comprehend and answer the questions on the patient- completed assessments and Informed Consent Form;

3. Patient was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test), including over-the-counter medications;

5. Patient has a history of at least one TDAE over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug and receiving medical coverage through a private insurance.

Exclusion Criteria

1. Patient is currently hospitalized;

2. Patient's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx testing;

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Vitals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ernie Lee, CHRS

Role: STUDY_DIRECTOR

First Vitals LLC

Other Identifiers

MIDAS

Identifier Type: -

Identifier Source: org_study_id