Special Drug Use-Results Survey of Lipitor Tablets

Hypercholesterolemia Clinical Trial

— ALWAYS  

Official title:

Special Drug Use-Results Survey of Lipitor Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446679
• Other study ID #: LIP003
• Status: Completed
• Phase: N/A
• First received: September 22, 2011
• Last updated: February 20, 2013
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: February 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24050
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• atrovastatin
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma LDL-C concentration		0, 4, 12 and 24 week	No
Primary	Change in rate of achievement of the category-specific target LDL-C level		0, 4, 12 and 24 week	No
Secondary	Change in plasma lipid values (LDL cholesterol, HDL cholesterol, triglycerides, total cholesterol, and malondialdehyde-modified LDL [MDL-LDL])		0, 4, 12 and 24 week	No
Secondary	Changes in renal function test values (urinary albumin, urinary creatinine, urinary protein, and serum creatinine)		0, 4, 12 and 24 week	No