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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening


Related Conditions & MeSH terms

  • Drug-Related Side Effects and Adverse Reactions

NCT number NCT02779530
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase Phase 4
Start date October 2011
Completion date July 2013

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