Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00473655
First received: May 14, 2007
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Hypertriglyceridemia
Hyperlipoproteinemia Type IV
Hyperlipoproteinemia Type V
Hyperlipoproteinemia Type IIb
Hyperlipidemia
Drug: rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Reduction from baseline to end of study


Secondary Outcome Measures:
  • Non-HDL-C Reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Reduction from baseline to end of study

  • LDL-C Reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Reduction from baseline to end of study

  • Total Cholesterol Reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Reduction from baseline to end of study

  • HDL-C Increase [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Increase from baseline to end of study

  • ApoA1 Levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in the levels from baseline to end of study

  • hsCRP Reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Reduction from baseline to end of study

  • Adverse Events Reported [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with AEs and SAEs reported

  • ApoB Levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in the levels from baseline to end of study


Enrollment: 334
Study Start Date: January 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rosuvastatin
    10mg or 20mg
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided by AstraZeneca

Additional 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
Study First Received: May 14, 2007
Results First Received: May 10, 2010
Last Updated: November 30, 2010
Health Authority: Mexico: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection

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

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

ClinicalTrials.gov processed this record on July 20, 2014