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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01241097
• Other study ID #: sxse
• Status: Recruiting
• Phase: N/A
• First received: November 15, 2010
• Last updated: November 15, 2010
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2010
• Source: Federal University of Bahia
• Contact: Maristela M Garcia, MD
• Phone: 55-71-99739981
• Email: marismacardiol[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with body mass index (BMI)> 25 kg / m²

• Aged > 18 years

• LDL-C> 100 mg / dl

Exclusion Criteria:

• Previous use of statins, fibrates or ezetimibe

• Triglycerides> 400 mg / dl

• Serum creatinine greater than 2.0 md / dl

• Elevated liver enzymes, more than one and half times the upper limit of normal

• Creatine kinase (CK) levels more than three times the upper limit of normal

• Pregnant

• Breast-feeding

• Heart failure

• Psychiatric disorders

• Hormone replacement therapy.

• The occurrence of recent onset within the last four weeks of treatment with beta-blockers, converting enzyme inhibitor or calcium channel blocker, the intervention should be undertaken after a period of at least four weeks of continuous use.

• Acute inflammatory processes in the last month, assessed by clinical history and physical examination (ear, throat, skin lesions or other inflammatory manifestations) as well as reports of chronic diseases such as collagen, or the occurrence of active tuberculosis in the last three months will be excluded from work.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Endothelial Function

Intervention

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

Locations

Country	Name	City	State
Brazil	Escola Bahiana de Medicina e Saúde Púiblica	Salvador	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Bahia	Escola Bahiana de Medicina e Saude Publica

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment.		8 weeks	Yes
Secondary	biochemical markers		8 weeks	Yes