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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01164397
First received: May 28, 2010
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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


Condition
Dyslipidemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 268
Study Start Date: April 2009
Study Completion Date: December 2010
Groups/Cohorts
Dislipidemic Population
People with high levels of total cholesterol, LDL, C-HDL and triglycerides

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Care clinic private practice

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164397

Locations
Mexico
Research Site
Mexico, DF, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Cuernavaca, Morelos, Mexico
Research Site
Monterrey, Nuevo Leon, Mexico
Research Site
Veracruz, Xalapa, Mexico
Research Site
Merida, Yucatan, Mexico
Research Site
Durango, Mexico
Research Site
Puebla, Mexico
Research Site
San Luis Potosi, Mexico
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Ana Polanco, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01164397     History of Changes
Other Study ID Numbers: NIS-CME-CRE-2010/1, DM-CRESTOR-0003
Study First Received: May 28, 2010
Last Updated: January 17, 2012
Health Authority: Mexico: Ethics Committee

Keywords provided by AstraZeneca:
Hypercholesterolemia
Statins

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Rosuvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014