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CompletedNCT01164397Updated Jan 18, 2012

Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin in Outpatients

An observational study in Dyslipidemia, sponsored by AstraZeneca. Completed at 9 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-18.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
268
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to evaluate the effectiveness of Rosuvastatin versus Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks.

02

Conditions studied

  • Dyslipidemia

Keywords

  • Hypercholesterolemia
  • Statins
03

In context

Dyslipidemias

1,101 studies on the registry are indexed under Dyslipidemias; 161 are open to participants now.

This study's enrollment of 268 is below the median of 600 across 212 observational studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Care clinic private practice

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Dislipidemic population treated with rosuvastatin or ezetimibe/simvastatin for at least for 8 weeks
  • Who have completed at least 80% of the treatment
  • To have determinations at least of CT, TG C-LDL and CHDL before starting treatment and after 8 weeks of taking the medicine

Exclusion criteria

Exclusion Criteria:

  • Initiating different therapy lipid lowering to Rosuvastatin or Ezetimibe/Simvastatin
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
268 participants (actual)

Groups and cohorts

  • Dislipidemic Population

    People with high levels of total cholesterol, LDL, C-HDL and triglycerides

06

What researchers measure

Primary outcomes

  1. The percentage of the patients that achieve the goal proposed for NCEP ATP III (2001 y 2004) will be assessed, to C-LDL in patients treated with Rosuvastatin or Ezetimibe/Simvastatin at least for 8 weeks.

    Time frame: Data will be collected using CRFs after complete at least 15 patients over a 24 week period.

Secondary outcomes

  1. The percentage of LDL-C reduction according to baseline levels in patients treated wuth Rosuvastatin or Ezetimibe/Simvastatin for at least 8 weeks.

    Time frame: Data will be collected using CRFs after complete at least 15 patients over a 24 week period.

07

Study locations

9 sites
  • Research Site
    Guadalajara, Jalisco, Mexico
  • Research Site
    Mexico City, Mexico City, Mexico
  • Research Site
    Cuernavaca, Morelos, Mexico
  • Research Site
    Monterrey, Nuevo León, Mexico
  • Research Site
    Puebla City, Puebla, Mexico
  • Research Site
    San Luis Potosí City, San Luis Potosí, Mexico
  • Research Site
    Veracruz, Xalapa, Mexico
  • Research Site
    Mérida, Yucatán, Mexico
  • Research Site
    Durango, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01164397
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jul 16, 2010
Start date
Apr 2009
Completion
Dec 2010
Last update
Jan 18, 2012

Study contacts

Ana Polanco, MD
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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