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Medication Optimisation for Reducing Events in a Private Practice Setting

NCT00653653 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2009-04-08

No results posted yet for this study

Summary

Using a prospective study design of two three month periods (before and after genotyping) in which the patients will self-monitor their health status and possible medical events it is hypothesized that it will be shown that patients having their medication altered to fit their genetic status and/or having their medication altered because of inherent interaction potential will have less recordable events after genotyping and medical analysis than before.

It is well known that ADRs (recordable adverse events to medication) are responsible for a large number of deaths and hospitalizations. Furthermore it is well recorded that genotyping of individual cytochrome P450 enzymes (2D6, 2C9, 2C19, among others) is directly related to a metabolic phenotype - fast metabolisers, slow metabolisers, intermediate and normal metabolisers. These differing phenotypes have altered metabolism of many medications and in a number of retrospective clinical trails it has been shown that ADRs and effect can be reduced/bettered through genotyping and alteration of medication.

Conditions

  • Pharmacogenetic Analysis to Reduce Events.

Sponsors & Collaborators

  • Awenydd GmbH

    lead INDUSTRY

Principal Investigators

  • Lee S Griffith, Ph.D. · Awenydd GmbH

  • André Gessner, MD Ph.D. · University of Erlangen-Nürnberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-06-30
Completion
2009-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00653653 on ClinicalTrials.gov