Pleiotropism of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe
NCT ID: NCT01241097
Last Updated: 2010-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2010-03-31
2011-12-31
Brief Summary
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* 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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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high-dose simvastatin, combined, 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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged \> 18 years
* LDL-C\> 100 mg / dl
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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Escola Bahiana de Medicina e Saude Publica
OTHER
Federal University of Bahia
OTHER
Responsible Party
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Escola Bahiana de Medicina e Saude Publica
Principal Investigators
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Maristela M Garcia, MD
Role: PRINCIPAL_INVESTIGATOR
Escola Bahiana de Medicina e Saúde Pública
Locations
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Escola Bahiana de Medicina e Saúde Púiblica
Salvador, Estado de Bahia, Brazil
Countries
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Central Contacts
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Facility Contacts
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Marilia G Rodrigues, MD
Role: primary
Paulo Roberto P Lima, student
Role: backup
Other Identifiers
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sxse
Identifier Type: -
Identifier Source: org_study_id