Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

November 30, 2010 updated by: AstraZeneca

A Double-blind, Double Dummy, Phase IV, Randomized, Multicenter, Parallel Group, Placebo Controlled Trial to Evaluate the Effect of Rosuvastatin on Triglycerides Levels in Mexican Hypertriglyceridemic Patients

The primary purpose of this trial is to determine if the treatment with rosuvastatin 10 and 20mg/day during 8 weeks in hypertriglyceridemic patients will reduce their triglyceride levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mexico City, DF, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18 years, both genders, without any previous treatment with statins or other lipid lowering drugs for at least 6 months
  • With elevated triglycerides above 200 and below 800mg/dl and willing to follow all study procedures including assisting to clinics, fasting before blood samples and signing a written consent

Exclusion Criteria:

  • High levels of low-density lipoprotein cholesterol (LDL-C)
  • Unstable cardiovascular condition or awaiting a myocardial revascularization
  • Congestive cardiac failure
  • Uncontrolled diabetes
  • Cancer
  • Uncontrolled hypothyroidism
  • Familial hypercholesterolemia
  • Liver/muscle disease
  • Pregnancy
  • Other

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)
Time Frame: 8 weeks
Reduction from baseline to end of study
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-HDL-C Reduction
Time Frame: 8 weeks
Reduction from baseline to end of study
8 weeks
LDL-C Reduction
Time Frame: 8 weeks
Reduction from baseline to end of study
8 weeks
Total Cholesterol Reduction
Time Frame: 8 weeks
Reduction from baseline to end of study
8 weeks
HDL-C Increase
Time Frame: 8 weeks
Increase from baseline to end of study
8 weeks
ApoA1 Levels
Time Frame: 8 weeks
Change in the levels from baseline to end of study
8 weeks
hsCRP Reduction
Time Frame: 8 weeks
Reduction from baseline to end of study
8 weeks
Adverse Events Reported
Time Frame: 8 weeks
Number of participants with AEs and SAEs reported
8 weeks
ApoB Levels
Time Frame: 8 weeks
Change in the levels from baseline to end of study
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Ana Polanco, MD, AstraZeneca Mexico
  • Study Chair: Ana Polanco, MD, AstraZeneca Mexico
  • Principal Investigator: Juan Talavera, MD, IMSS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

May 14, 2007

First Submitted That Met QC Criteria

May 14, 2007

First Posted (Estimate)

May 15, 2007

Study Record Updates

Last Update Posted (Estimate)

December 16, 2010

Last Update Submitted That Met QC Criteria

November 30, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM-CRESTOR-0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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