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Diagnosing Adverse Drug Reactions Registry (DART)

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ClinicalTrials.gov Identifier: NCT01970709
Recruitment Status : Unknown
Verified March 2015 by Renaissance RX.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2013
Last Update Posted : March 19, 2015
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
Renaissance RX

October 22, 2013
October 28, 2013
March 19, 2015
November 2013
November 2015   (Final data collection date for primary outcome measure)
Occurrence of meaningful change in drug regimen [ Time Frame: 60 days ]
The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when:
  • A genotype known to affect a drug the subject is taking is identified, and
  • The subject's treating physician makes at least one drug regimen change in concordance with the PharmD recommendations.
Occurrence of meaningful change in drug regimen [ Time Frame: 60 days ]
The primary outcome measure is the binary occurrence of meaningful change in drug regimen, defined in each subject when:
  • A genotype known to affect a drug the subject is taking is identified, and
  • The subject's treating physician makes at least one drug regimen change in concordance with the PharmD recommendations.
Complete list of historical versions of study NCT01970709 on ClinicalTrials.gov Archive Site
  • 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 ]
    Emergency department visits over the 12 months prior to enrollment, emergency department visits over the 60 days following receipt of test results, hospitalizations over the 12 months prior to enrollment, and hospitalizations over the 60 days following receipt of test results.
Same as current
Not Provided
Not Provided
 
Diagnosing Adverse Drug Reactions Registry
DART Registry: Diagnosing Adverse Drug Reactions Registry
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.
Not Provided
Observational [Patient Registry]
Observational Model: Cohort
60 Days
Retention:   Samples With DNA
Description:
Buccal swab
Non-Probability Sample
Male and female subjects over the age of 18, taking three or more medications, two of which are metabolized by the CYP450 pathway.
Genetics of Drug Metabolism
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
250000
Same as current
Not Provided
November 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01970709
2013-101
No
Not Provided
Not Provided
Renaissance RX
Renaissance RX
Syntactx
Not Provided
Renaissance RX
March 2015