This trial is active, not recruiting.

Condition genetics of drug metabolism
Sponsor Renaissance RX
Collaborator Syntactx
Start date November 2013
End date November 2015
Trial size 250000 participants
Trial identifier NCT01970709, 2013-101


This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and hospitalizations) associated with ADR.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort

Primary Outcomes

Occurrence of meaningful change in drug regimen
time frame: 60 days

Secondary Outcomes

Change in the regimen of drugs controlled by genes of interest over the 12 months prior to enrollment and change in the regimen of drugs controlled by genes of interest over the 60 days following receipt of pharmacogenetic test results.
time frame: 60 days
Number of ADR per month over the 12 months prior to enrollment and number of ADR per month over the 60 days following receipt of pharmacogenomic test results.
time frame: 60 days
Frequency of genome-based PharmD recommendations to alter drug or dose.
time frame: 60 days
Emergency department visits and hospitalizations
time frame: 60 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject has care coordinated at the treating physician's outpatient clinic; - Subject has provided written informed consent; - Subject is taking at least three (3) regularly scheduled medications, excluding as needed (PRN) medications, over the counter medications and nutritional supplements; two (2) of which are known to be affected by genetic allelic variation. - Subject's treating physician has a clinical suspicion that the subject is experiencing adverse signs or symptoms related to a prescribed medication or is not achieving the intended effect from the medication. Exclusion Criteria: - Subject has a history of chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5; - Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) >1.5x normal, or suspected cirrhosis); - Subject has a history of malabsorption (short gut syndrome); - Subject has a history of any gastric or small bowel surgery; - Subject is currently hospitalized; - Subject is currently being treated with intravenous medication; - Subject underwent prior pharmacogenomic testing with results reported within the last 12 months. Subjects may be eligible within 60 days from the date of pharmacogenomic testing.

Additional Information

Official title DART Registry: Diagnosing Adverse Drug Reactions Registry
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Renaissance RX.