drugset / Trial / NCT02779530
CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs
RandomizedCrossoverDouble-blindScreening
Summary
Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the CYP4F2 V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According the sample size planned, a mean difference of total body water delta between groups (control vs. polymorphic) of at least allow 10% could be observed.
Timeline
- Start
- 2011-10
- Primary completion
- 2013-07
- Completion
- 2013-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diclofenac | Other / unclassified | 50 mg | Oral |