Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

This study has been completed.
Sponsor:
Information provided by:
Kowa Research Europe
ClinicalTrials.gov Identifier:
NCT00309751
First received: December 8, 2005
Last updated: February 17, 2010
Last verified: February 2010

December 8, 2005
February 17, 2010
December 2005
June 2007   (final data collection date for primary outcome measure)
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline LDL-C
Complete list of historical versions of study NCT00309751 on ClinicalTrials.gov Archive Site
Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in lipid and lipoprotein measures
  • Safety and tolerability
Not Provided
Not Provided
 
Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type II Diabetes Mellitus
  • Dyslipidemia
  • Drug: Pitavastatin
    Pitavastatin 4 mg QD
  • Drug: Atorvastatin
    Atorvastatin 20 mg
    Other Name: Lipitor
  • Experimental: Pitavastatin 4 mg QD
    Pitavastatin 4 mg once daily
    Intervention: Drug: Pitavastatin
  • Active Comparator: Atorvastatin 20 mg QD
    Atorvastatin 20 mg once daily
    Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
418
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females (ages 18-75 years)
  • Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
  • Must have been following a restrictive diet
  • Diagnosis of combined dyslipidemia

Exclusion Criteria:

  • Homozygous familial hypercholesterolemia
  • Conditions which may cause secondary dyslipidemia
  • Uncontrolled diabetes mellitus
  • Abnormal pancreatic, liver, or renal function
  • Abnormal serum creatine kinase (CK) above the pre-specified level
  • Significant heart disease
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   India,   Netherlands,   Poland,   United Kingdom
 
NCT00309751
NK-104-305
No
Dragos Budinski, MD, Kowa Research Europe
Kowa Research Europe
Not Provided
Study Director: Dragos Budinski, Med Dr. Kowa Research Europe
Kowa Research Europe
February 2010

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