Effect of Rosuvastatin on Triglyceride Levels in Mexican Hypertriglyceridemic Patients

AstraZeneca

Status and phase: Completed; Phase 4

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

Treatments: Drug: rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00473655

DM-CRESTOR-0002

Details and patient eligibility

About

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.

Enrollment: 334 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind