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OpenTrials
Completed

NCT Number: NCT01446679

Special Drug Use-Results Survey of Lipitor Tablets

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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Chugoku, Japan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atrovastatin

Drug

oral

Other names: Lipitor

Primary outcomes

  1. Changes in plasma LDL-C concentration

    Time frame: 0, 4, 12 and 24 week

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

    Time frame: 0, 4, 12 and 24 week

Secondary outcomes

  1. 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

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

    Time frame: 0, 4, 12 and 24 week

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Acronym: ALWAYS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2011
Registry last updated
Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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