Endothelial Function Clinical Trial
Official title:
Comparison of the Effect on Endothelial Function of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe
- To test the hypothesis that therapy with high dose statin provides endothelial superior
benefit to the same cholesterol lowering with low-dose statin combined with ezetimibe.
- To test the hypothesis that therapy with high dose statin provides anti-inflammatory
effect than the same reduction of cholesterol with low dose of statin plus ezetimibe
Randomized, double-blind, placebo-controlled study. Inclusion Criteria: Obese women with
body mass index (BMI)> 25 kg / m², aged 18 years and LDL-C> 100 mg / dl For treatment with
simvastatin 80 mg, the participant will receive two identical vials, each containing a
simvastatin 40 mg. For treatment with the combination simvastatin 10 mg and ezetimibe 10 mg,
the participant will receive two identical bottles, one bottle with simvastatin 10 mg, and
another bottle with ezetimibe 10mg. In the control group, each participant will receive two
identical bottles, each bottle containing inert tablets. Each group with 20 participants.
Dependent Variable (Final Primary Outcome): Percentage change vasodilation of brachial
artery flow-mediated, after treatment for eight weeks.
Covariates: clinical, biochemical markers and ultrasound.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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