Reduction of Adverse Drug Events and Readmissions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25+
SponsorClinLogic LLC
About this trial
Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Radar, Pharmocogenomic
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov