Special Drug Use-Results Survey of Lipitor Tablets

Astellas Pharma Inc24,050 enrolled

Overview

This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve the category-specific targeted lipid levels.

To confirm the low-density lipoprotein cholesterol (LDL-C)-lowering effect of 24 weeks of treatment with Lipitor®(Generic Name : atorvastatin calcium) Tablets and determine the rate of achievement of the category-specific target LDL-C level in patients with hypercholesterolemia; and to confirm the usefulness (efficacy and safety) of atorvastatin in patients who have not responded sufficiently to other statin therapies

Study Type

OBSERVATIONAL

Enrollment

24,050

Conditions

Hypercholesterolemia

Interventions

atrovastatinDRUG

oral

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Patients with hypercholesterolemia who have not achieved the category-specific target lipid level

Locations (8)

Unnamed facility

Chugoku, Japan

Unnamed facility

Chūbu, Japan

Unnamed facility

Hokkaido, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kantou, Japan

Outcomes

Primary Outcomes

Changes in plasma LDL-C concentration

Time frame: 0, 4, 12 and 24 week

Change in rate of achievement of the category-specific target LDL-C level

Time frame: 0, 4, 12 and 24 week

Secondary Outcomes

Change in plasma lipid values (LDL cholesterol, HDL cholesterol, triglycerides, total cholesterol, and malondialdehyde-modified LDL [MDL-LDL])

Time frame: 0, 4, 12 and 24 week

Changes in renal function test values (urinary albumin, urinary creatinine, urinary protein, and serum creatinine)

Time frame: 0, 4, 12 and 24 week

Data from ClinicalTrials.gov

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