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Sponsored by: |
Awenydd GmbH |
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Information provided by: | Awenydd GmbH |
ClinicalTrials.gov Identifier: | NCT00653653 |
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.
Condition |
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Pharmacogenetic Analysis to Reduce Events. |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice. |
Estimated Enrollment: | 500 |
Study Start Date: | August 2008 |
Groups/Cohorts |
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Group A
Recruited patients will be prospectively observed as one cohort with genotyping/medication interaction analysis after 3 months, followed up by a further 3 month observational period.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Community sample.
Inclusion Criteria:
Exclusion Criteria:
Contact: Lee S Griffith, Ph.D. | +49 170-3828071 | ls.griffith@awenydd.de |
Contact: André Gessner, MD Ph.D. | 09131-8522580 |
Germany, BW | |
Awenydd Gmbh | Recruiting |
Freiburg, BW, Germany, 79108 | |
Contact: Lee S Griffith, PhD +49 170-3828071 ls.griffith@awenydd.de | |
Contact: Peter Kischkewitz +49-761-51589 ext 0 p.kischkewitz@awenydd.de | |
Principal Investigator: Lee S Griffith, Ph.D. |
Study Director: | Lee S Griffith, Ph.D. | Awenydd GmbH |
Principal Investigator: | André Gessner, MD Ph.D. | University of Erlangen |
Responsible Party: | awenydd Gene Diagnostic ( Dr. LS Griffith ) |
Study ID Numbers: | AW_SH_08 |
Study First Received: | April 2, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00653653 |
Health Authority: | Germany: Federal Ministry of Education and Research |
pharmacogenetics pharmacoeconomics adverse events drug metabolism |