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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01446679
First received: September 22, 2011
Last updated: February 20, 2013
Last verified: February 2013
  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 ] [ Designated as safety issue: No ]
  • Change in rate of achievement of the category-specific target LDL-C level [ Time Frame: 0, 4, 12 and 24 week ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Changes in renal function test values (urinary albumin, urinary creatinine, urinary protein, and serum creatinine) [ Time Frame: 0, 4, 12 and 24 week ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01446679     History of Changes
Other Study ID Numbers: LIP003
Study First Received: September 22, 2011
Last Updated: February 20, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on April 14, 2014