NCT01970709Unknown不适用
DART Registry: Diagnosing Adverse Drug Reactions Registry
Renaissance RX49 个研究点 分布在 1 个国家目标入组 250,000 人开始时间: 2013年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250,000
- 试验地点
- 49
- 主要终点
- Occurrence of meaningful change in drug regimen
研究概览
简要总结
This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and hospitalizations) associated with ADR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has care coordinated at the treating physician's outpatient clinic;
- •Subject has provided written informed consent;
- •Subject is taking at least three (3) regularly scheduled medications, excluding as needed (PRN) medications, over the counter medications and nutritional supplements; two (2) of which are known to be affected by genetic allelic variation.
- •Subject's treating physician has a clinical suspicion that the subject is experiencing adverse signs or symptoms related to a prescribed medication or is not achieving the intended effect from the medication.
排除标准
- •Subject has a history of chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5;
- •Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) >1.5x normal, or suspected cirrhosis);
- •Subject has a history of malabsorption (short gut syndrome);
- •Subject has a history of any gastric or small bowel surgery;
- •Subject is currently hospitalized;
- •Subject is currently being treated with intravenous medication;
- •Subject underwent prior pharmacogenomic testing with results reported within the last 12 months.
- •Subjects may be eligible within 60 days from the date of pharmacogenomic testing.
结局指标
主要结局
Occurrence of meaningful change in drug regimen
时间窗: 60 days
The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when: * A genotype known to affect a drug the subject is taking is identified, and * The subject's treating physician makes at least one drug regimen change in concordance with the PharmD recommendations.
次要结局
- Change in the regimen of drugs controlled by genes of interest over the 12 months prior to enrollment and change in the regimen of drugs controlled by genes of interest over the 60 days following receipt of pharmacogenetic test results.(60 days)
- Number of ADR per month over the 12 months prior to enrollment and number of ADR per month over the 60 days following receipt of pharmacogenomic test results.(60 days)
- Emergency department visits and hospitalizations(60 days)
- Frequency of genome-based PharmD recommendations to alter drug or dose.(60 days)
研究者
研究点 (49)
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