This trial is active, not recruiting.

Condition pharmacogenetic analysis to reduce events.
Sponsor Awenydd GmbH
Start date August 2008
End date June 2009
Trial size 500 participants
Trial identifier NCT00653653, AW_SH_08


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.

Primary Outcomes

Reduction of reported events in the time frame.
time frame: 3 months

Secondary Outcomes

Reduction of total costs associated per patient in the time frame.
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - older than 18 years - not demented - 1 or more documented events in the previous 6 months. - more than one medication - multi-morbid Exclusion Criteria: - demented - life expectancy less than 1 year - heart attack within the last 6 months - Marcumar® Therapy

Additional Information

Official title Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice.
Principal investigator André Gessner, MD Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Awenydd GmbH.