Medication Optimisation for Reducing Events in a Private Practice Setting

NCT ID: NCT00653653

Last Updated: 2009-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-10-31

Brief 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.

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Awenydd GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

awenydd Gene Diagnostic

Principal Investigators

Lee S Griffith, Ph.D.

Role: STUDY_DIRECTOR

Awenydd GmbH

André Gessner, MD Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen-Nürnberg

Locations

Awenydd Gmbh

Cologne, North Rhine-Westphalia, Germany

Countries

Germany

References

Chialda L, Griffith LS, Heinig A, Pahl A. Prospective use of CYP pharmacogenetics and medication analysis to facilitate improved therapy - a pilot study. Per Med. 2008 Jan;5(1):37-45. doi: 10.2217/17410541.5.1.37.

Reference Type: BACKGROUND

PMID: 29783392 (View on PubMed)

Other Identifiers

AW_SH_08

Identifier Type: -

Identifier Source: org_study_id