Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Metabolic Syndrome

Treatments: Drug: rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00815659

D3560L00079

Details and patient eligibility

About

The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.

Enrollment: 97 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria)
• LDL-Cholesterol > 130mg/dl
• HDL-Cholesterol < 40mg/dl in males and <50mg/dl in females
• Triglycerides < 400 mg/dl

Exclusion criteria

• With a concomitant coronary disease
• Currently under statin therapy or previously treated with statins within the last 6 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

Rosuvastatin

Experimental group

Description:

medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.

Treatment:

Drug: rosuvastatin