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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Federal University of Bahia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Escola Bahiana de Medicina e Saude Publica
Information provided by:
Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT01241097
First received: November 15, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted

November 15, 2010
November 15, 2010
March 2010
December 2010   (final data collection date for primary outcome measure)
Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
biochemical markers [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
  • 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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Endothelial Function
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
Other Name: zocor, vytorin
Experimental: 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
Intervention: Drug: simvastatin, combined with simvastatin ezetimibe, placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2011
December 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
Yes
Contact: Maristela M Garcia, MD 55-71-99739981 marismacardiol@gmail.com
Contact: Luis Claudio L Correia, Phd 55-71-99711032 lccorreia@terra.com.br
Brazil
 
NCT01241097
sxse
Yes
Luis Claudio Lemos Correia, Phd, Escola Bahiana de Medicina e Saude Publica
Federal University of Bahia
Escola Bahiana de Medicina e Saude Publica
Principal Investigator: Maristela M Garcia, MD Escola Bahiana de Medicina e Saúde Pública
Federal University of Bahia
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP