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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

September 22, 2011
February 20, 2013
September 2010
March 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01446679 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Special Drug Use-Results Survey of Lipitor Tablets
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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with hypercholesterolemia who have not achieved the category-specific target lipid level in other statin therapies

Hypercholesterolemia
Drug: atrovastatin
oral
Other Name: Lipitor
atrovastatin group
Who receive atrovastatin
Intervention: Drug: atrovastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24050
March 2012
March 2012   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01446679
LIP003
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contract Astellas Pharma Inc
Astellas Pharma Inc
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP