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Special Drug Use-Results Survey of Lipitor Tablets (ALWAYS)

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ClinicalTrials.gov Identifier: NCT01446679
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hypercholesterolemia Drug: atrovastatin

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 Type : Observational
Actual Enrollment : 24050 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use-Results Survey of Lipitor Tablets
Study Start Date : September 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012


Group/Cohort Intervention/treatment
atrovastatin group
Who receive atrovastatin
Drug: atrovastatin
oral
Other Name: Lipitor




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hypercholesterolemia who have not achieved the category-specific target lipid level in other statin therapies
Criteria
Patients with hypercholesterolemia who have not achieved the category-specific target lipid level

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446679


Locations
Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contract Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01446679     History of Changes
Other Study ID Numbers: LIP003
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Astellas Pharma Inc:
Lipitor
HMG-CoA reductase inhibitor

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors