NCT02779530

CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs

Evaluation of CYP4A11 and CYP4F2 Gene Variants as Makers in Edema and Elevated Blood Pressure Occurrence After Nonsteroidal Anti-inflammatory (NSAID) Use

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Eduardo Barbosa Coelho · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Drug-Related Side Effects and Adverse Reactions

Interventions

Type	Name	Description
DRUG	Diclofenac	50 mg po, b.i.d for 6 days
OTHER	Placebo	Placebo po, b.i.d. for 6 days

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2016-05-20
• Last updated: 2016-05-20

Locations

1 site across 1 country: Brazil