Reduction of Adverse Drug Events and Readmissions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pharmacogenomic Testing for Medication Management. Basic parameters: from 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pharmacogenomic Test Assessment for Medication Management in the Advancement of Medicine
Overview
Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.
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.
Primary outcome measures
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- MD@Home — York
Identifiers
NCT: NCT02738047 · 10202016