Clinical trial NCT02559193: Pharmacogenetic Testing for Medication Management.
Official title: Medication Interactions to Detect Adverse Situations
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Medication Management
Lead sponsor: First Vitals LLC
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The Study will include male or female patients 18 years of or older who are receiving at least one medication with metabolism known to depend on genetic variation and have the PGx test already performed. The patient must also meet the inclusion/ exclusion criteria established by the protocol.

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.

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.

Primary outcomes:
measure: The primary endpoint of the Study is the binary occurrence of meaningful change in drug regimen.
timeFrame: 90-day period following receipt of PGx test results
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Vitals LLC
name: Ernie Lee, CHRS
role: STUDY_DIRECTOR
References: