Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

AstraZeneca334 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

334

Conditions

Hypertriglyceridemia Hyperlipoproteinemia Type IV Hyperlipoproteinemia Type V Hyperlipoproteinemia Type IIb Hyperlipidemia

Interventions

rosuvastatinDRUG

10mg or 20mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Research Site

Guadalajara, Jalisco, Mexico

Research Site

Mexico City, Mexico City, Mexico

Research Site

Monterrey, Nuevo León, Mexico

Outcomes

Primary Outcomes

Change (Reduction) in Triglycerides Levels From Baseline to End of Treatment (Week 8)

Reduction from baseline to end of study

Time frame: 8 weeks

Secondary Outcomes

Non-HDL-C Reduction

Reduction from baseline to end of study

Time frame: 8 weeks

LDL-C Reduction

Reduction from baseline to end of study

Time frame: 8 weeks

Total Cholesterol Reduction

Reduction from baseline to end of study

Time frame: 8 weeks

HDL-C Increase

Increase from baseline to end of study

Time frame: 8 weeks

ApoA1 Levels

Change in the levels from baseline to end of study

Time frame: 8 weeks

hsCRP Reduction

Reduction from baseline to end of study

Time frame: 8 weeks

Adverse Events Reported

Number of participants with AEs and SAEs reported

Time frame: 8 weeks

ApoB Levels

Change in the levels from baseline to end of study

Time frame: 8 weeks

Data from ClinicalTrials.gov

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