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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01446679
First Posted: October 5, 2011
Last Update Posted: February 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve the category-specific targeted lipid levels.

Condition Intervention
Hypercholesterolemia Drug: atrovastatin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use-Results Survey of Lipitor Tablets

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 24050
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
atrovastatin group
Who receive atrovastatin
Drug: atrovastatin
oral
Other Name: Lipitor

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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
  More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01446679     History of Changes
Other Study ID Numbers: LIP003
First Submitted: September 22, 2011
First Posted: October 5, 2011
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