Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

Phase 4

Completed

• Conditions: Hypertriglyceridemia; Hyperlipoproteinemia Type IV; Hyperlipoproteinemia Type V; Hyperlipoproteinemia Type IIb; Hyperlipidemia

• Registration Number: NCT00473655
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-05-14
• Study First Submitted QC: 2007-05-14
• Study First Posted: 2007-05-15
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2010-05-10
• Results First Submitted QC: 2010-05-10
• Results First Posted: 2010-06-08
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-30
• Last Update Posted: 2010-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)	8 weeks	Reduction from baseline to end of study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇲🇽 Monterrey, Nuevo Leon, Mexico