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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014