Clinical Trial: Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) [ Time Frame: 8 weeks ]

Reduction from baseline to end of study


Original Primary Outcome: Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)

Current Secondary Outcome:

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


Original Secondary Outcome:

Information By: AstraZeneca

Dates:
Date Received: May 14, 2007
Date Started: January 2007
Date Completion:
Last Updated: November 30, 2010
Last Verified: November 2010