NCT01241097

Pleiotropism of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe

Comparison of the Effect on Endothelial Function of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Federal University of Bahia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

* 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

Detailed description

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.

Conditions

• Endothelial Function

Interventions

Type	Name	Description
DRUG	simvastatin, combined with simvastatin ezetimibe, placebo	simvastatin 80 mg per days or simvastatin 10 mg and ezetimibe 10 mg, over a period of eight weeks, treatment consisted of tablets identical, or placebo

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2010-11-16
• Last updated: 2010-11-16

Locations

1 site across 1 country: Brazil