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
1 other identifier
interventional
60
1 country
1
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 hypothesis that therapy with high dose statin provides anti-inflammatory effect than the same reduction of cholesterol with low dose of statin plus ezetimibe
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 15, 2010
CompletedFirst Posted
Study publicly available on registry
November 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 16, 2010
June 1, 2010
9 months
November 15, 2010
November 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment.
8 weeks
Secondary Outcomes (1)
biochemical markers
8 weeks
Study Arms (1)
high-dose simvastatin, combined, placebo
EXPERIMENTALsimvastatin 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
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
Eligibility Criteria
You may qualify if:
- Women with body mass index (BMI)\> 25 kg / m²
- Aged \> 18 years
- LDL-C\> 100 mg / dl
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Escola Bahiana de Medicina e Saúde Púiblica
Salvador, Estado de Bahia, 40000, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maristela M Garcia, MD
Escola Bahiana de Medicina e Saúde Pública
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 15, 2010
First Posted
November 16, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
November 16, 2010
Record last verified: 2010-06