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NCT01164397 Clinical Trial

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

Dyslipidemia Clinical Trial

Official title:
Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin to Reduce the Cholesterol Levels in Outpatients in a Realistic Environment. A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01164397
Other study ID # NIS-CME-CRE-2010/1
Secondary ID DM-CRESTOR-0003
Status Completed
Phase N/A
First received May 28, 2010
Last updated January 17, 2012
Start date April 2009
Est. completion date December 2010

Study information
Verified date January 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Mexico: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 268
Est. completion date December 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

- Initiating different therapy lipid lowering to Rosuvastatin or Ezetimibe/Simvastatin

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Mexico Research Site Cuernavaca Morelos
Mexico Research Site Durango
Mexico Research Site Guadalajara Jalisco
Mexico Research Site Merida Yucatan
Mexico Research Site Mexico DF
Mexico Research Site Monterrey Nuevo Leon
Mexico Research Site Puebla
Mexico Research Site San Luis Potosi
Mexico Research Site Veracruz Xalapa

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Data will be collected using CRFs after complete at least 15 patients over a 24 week period. Yes
Secondary The percentage of LDL-C reduction according to baseline levels in patients treated wuth Rosuvastatin or Ezetimibe/Simvastatin for at least 8 weeks. Data will be collected using CRFs after complete at least 15 patients over a 24 week period. Yes
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