Status:
UNKNOWN
Pleiotropism of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe
Lead Sponsor:
Federal University of Bahia
Collaborating Sponsors:
Escola Bahiana de Medicina e Saude Publica
Conditions:
Endothelial Function
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 hypothesi...
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,...
Eligibility Criteria
Inclusion
- Women with body mass index (BMI)\> 25 kg / m²
- Aged \> 18 years
- LDL-C\> 100 mg / dl
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01241097
Start Date
March 1 2010
End Date
December 1 2011
Last Update
November 16 2010
Active Locations (1)
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1
Escola Bahiana de Medicina e Saúde Púiblica
Salvador, Estado de Bahia, Brazil, 40000