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 ]
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