Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertriglyceridemia, Hyperlipoproteinemia Type IV, Hyperlipoproteinemia Type V, Hyperlipoproteinemia Type IIb, Hyperlipidemia

Intervention / Treatment
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* Drug: rosuvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rosuvastatin|10mg or 20mg|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8) | Reduction from baseline to end of study | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triglycerides, hypertriglyceridemia, statins, rosuvastatin, hyperlipoproteinemia, Fredrickson Type IIb or IV