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
  Purpose
  • 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

Condition Intervention
Endothelial Function
Drug: simvastatin, combined with simvastatin ezetimibe, placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Comparison of the Effect on Endothelial Function of Statin Therapy in High Dose Versus Low Dose Combined With Ezetimibe

Resource links provided by NLM:


Further study details as provided by Federal University of Bahia:

Primary Outcome Measures:
  • Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • biochemical markers [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241097

Contacts
Contact: Maristela M Garcia, MD 55-71-99739981 marismacardiol@gmail.com
Contact: Luis Claudio L Correia, Phd 55-71-99711032 lccorreia@terra.com.br

Locations
Brazil
Escola Bahiana de Medicina e Saúde Púiblica Recruiting
Salvador, Bahia, Brazil, 40000
Contact: Marilia G Rodrigues, MD    55-71-3359485    mgaleffi@cardiol.br   
Contact: Paulo Roberto P Lima, student    55-71-99184765    prpassoslima@hotmail.com   
Sub-Investigator: Carolina Garcez, student         
Sponsors and Collaborators
Federal University of Bahia
Escola Bahiana de Medicina e Saude Publica
Investigators
Principal Investigator: Maristela M Garcia, MD Escola Bahiana de Medicina e Saúde Pública
  More Information

No publications provided

Responsible Party: Luis Claudio Lemos Correia, Phd, Escola Bahiana de Medicina e Saude Publica
ClinicalTrials.gov Identifier: NCT01241097     History of Changes
Other Study ID Numbers: sxse
Study First Received: November 15, 2010
Last Updated: November 15, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Bahia:
endothelial function
statins
ezetimibe
pleiotropism

Additional relevant MeSH terms:
Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014