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临床试验/NCT00653653
NCT00653653Unknown不适用

Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice.

Awenydd GmbH1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Reduction of reported events in the time frame.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • older than 18 years
  • not demented
  • 1 or more documented events in the previous 6 months.
  • more than one medication
  • multi-morbid

排除标准

  • life expectancy less than 1 year
  • heart attack within the last 6 months
  • Marcumar® Therapy

结局指标

主要结局

Reduction of reported events in the time frame.

时间窗: 3 months

次要结局

  • Reduction of total costs associated per patient in the time frame.(3 months)

研究者

发起方
Awenydd GmbH
申办方类型
Industry

研究点 (1)

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