NCT01164397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

First QC Date

May 28, 2010

Last Update Submit

January 17, 2012

Conditions

Dyslipidemia

Keywords

HypercholesterolemiaStatins

Outcome Measures

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.

    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.

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

Study Arms (1)

Dislipidemic Population

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Care clinic private practice

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Guadalajara, Jalisco, Mexico

Location

Research Site

Mexico City, Mexico City, Mexico

Location

Research Site

Cuernavaca, Morelos, Mexico

Location

Research Site

Monterrey, Nuevo León, Mexico

Location

Research Site

Puebla City, Puebla, Mexico

Location

Research Site

San Luis Potosí City, San Luis Potosí, Mexico

Location

Research Site

Veracruz, Xalapa, Mexico

Location

Research Site

Mérida, Yucatán, Mexico

Location

Research Site

Durango, Mexico

Location

MeSH Terms

Conditions

DyslipidemiasHypercholesterolemia

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemias

Study Officials

  • Ana Polanco, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2010

First Posted

July 16, 2010

Study Start

April 1, 2009

Study Completion

December 1, 2010

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

ME(9)