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Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

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ClinicalTrials.gov Identifier: NCT00473655
Recruitment Status : Completed
First Posted : May 15, 2007
Results First Posted : June 8, 2010
Last Update Posted : December 16, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Hyperlipoproteinemia Type IV Hyperlipoproteinemia Type V Hyperlipoproteinemia Type IIb Hyperlipidemia Drug: rosuvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009



Intervention Details:
  • Drug: rosuvastatin
    10mg or 20mg


Primary Outcome Measures :
  1. Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) [ Time Frame: 8 weeks ]
    Reduction from baseline to end of study


Secondary Outcome Measures :
  1. Non-HDL-C Reduction [ Time Frame: 8 weeks ]
    Reduction from baseline to end of study

  2. LDL-C Reduction [ Time Frame: 8 weeks ]
    Reduction from baseline to end of study

  3. Total Cholesterol Reduction [ Time Frame: 8 weeks ]
    Reduction from baseline to end of study

  4. HDL-C Increase [ Time Frame: 8 weeks ]
    Increase from baseline to end of study

  5. ApoA1 Levels [ Time Frame: 8 weeks ]
    Change in the levels from baseline to end of study

  6. hsCRP Reduction [ Time Frame: 8 weeks ]
    Reduction from baseline to end of study

  7. Adverse Events Reported [ Time Frame: 8 weeks ]
    Number of participants with AEs and SAEs reported

  8. ApoB Levels [ Time Frame: 8 weeks ]
    Change in the levels from baseline to end of study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473655


Locations
Mexico
Research Site
Mexico City, DF, Mexico
Research Site
Guadalajara, Jalisco, Mexico
Research Site
Monterrey, Nuevo Leon, Mexico
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Ana Polanco, MD AstraZeneca Mexico
Study Chair: Ana Polanco, MD AstraZeneca Mexico
Principal Investigator: Juan Talavera, MD IMSS

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00473655     History of Changes
Other Study ID Numbers: DM-CRESTOR-0002
First Posted: May 15, 2007    Key Record Dates
Results First Posted: June 8, 2010
Last Update Posted: December 16, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Triglycerides
hypertriglyceridemia
statins
rosuvastatin
hyperlipoproteinemia
Fredrickson Type IIb or IV

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Hypertriglyceridemia
Hyperlipoproteinemia Type IV
Hyperlipoproteinemia Type II
Hyperlipidemia, Familial Combined
Hyperlipoproteinemia Type V
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors