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Status unknownNCT01241097Updated Nov 16, 2010

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

An interventional study of simvastatin, combined with simvastatin ezetimibe, placebo in Endothelial Function, sponsored by Federal University of Bahia. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-16.

Sponsored by Federal University of Bahia · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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
Read the 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.

02

Conditions studied

  • Endothelial Function

Keywords

  • endothelial function
  • statins
  • ezetimibe
  • pleiotropism
03

In context

Lead sponsor

Federal University of Bahia is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women with body mass index (BMI)> 25 kg / m²
  • Aged > 18 years
  • LDL-C> 100 mg / dl

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

  • Drugsimvastatin, 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

    Also known as: zocor, vytorin

06

What researchers measure

Primary outcomes

  1. Percent change vasodilation of brachial artery flow-mediated, after eight weeks of treatment.

    Time frame: 8 weeks

Secondary outcomes

  1. biochemical markers

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Escola Bahiana de Medicina e Saúde Púiblica
    Salvador, Bahia 40000, Brazil
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01241097
Lead sponsor
Federal University of Bahia
Collaborators
Escola Bahiana de Medicina e Saude Publica
First posted
Nov 16, 2010
Start date
Mar 2010
Primary completion
Dec 2010 (estimated)
Completion
Dec 2011 (estimated)
Last update
Nov 16, 2010

Study contacts

Maristela M Garcia, MD
Contact
marismacardiol@gmail.com
55-71-99739981
Luis Claudio L Correia, Phd
Contact
lccorreia@terra.com.br
55-71-99711032
Maristela M Garcia, MD
principal investigator · Escola Bahiana de Medicina e Saúde Pública

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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