Special Drug Use-Results Survey of Lipitor Tablets

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: atrovastatin

• Registration Number: NCT01446679
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-10-03
• Study First Posted: 2011-10-05
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24050

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
atrovastatin group	atrovastatin	Who receive atrovastatin

Primary Outcome Measures

Name	Time	Method
Changes in plasma LDL-C concentration	0, 4, 12 and 24 week
Change in rate of achievement of the category-specific target LDL-C level	0, 4, 12 and 24 week

Secondary Outcome Measures

Name	Time	Method
Changes in renal function test values (urinary albumin, urinary creatinine, urinary protein, and serum creatinine)	0, 4, 12 and 24 week
Change in plasma lipid values (LDL cholesterol, HDL cholesterol, triglycerides, total cholesterol, and malondialdehyde-modified LDL [MDL-LDL])	0, 4, 12 and 24 week