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

Completed

• Conditions: Dyslipidemia

• Registration Number: NCT01164397
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Study Completion: 2010-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-17
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇲🇽 San Luis Potosi, Mexico