Follow-On Study of Pitavastatin Versus 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:
NCT00344370
First received: June 23, 2006
Last updated: January 25, 2010
Last verified: January 2010

June 23, 2006
January 25, 2010
August 2006
April 2008   (final data collection date for primary outcome measure)
NCEP LDL-C Target Attainment [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
LDL-C target attainment according to EAS and NCEP definitions
Complete list of historical versions of study NCT00344370 on ClinicalTrials.gov Archive Site
Percent Change From Baseline in LDL-C [ Time Frame: Basseline to 44 weeks ] [ Designated as safety issue: No ]
  • LDL-C
  • TC
  • HDL-C
  • TC:HDL-C ratio
  • apolipoprotein profile
Not Provided
Not Provided
 
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Double-Blind, Follow-On Study of Pitavastatin (4 mg) Versus Atorvastatin (20 mg and 40 mg), With a Single-Blind Extension of Treatment, in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.

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
    Other Name: Livalo
  • Drug: Atorvastatin
    Atorvastatin 40 mg
    Other Name: Lipitor
  • Experimental: Pitavastatin
    Pitavastatin 4 mg QD
    Intervention: Drug: Pitavastatin
  • Active Comparator: Atorvastatin
    Atorvastatin 40 mg
    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
214
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type II diabetes mellitus
  • Combined dyslipidemia
  • Completed NK-104-305 (NCT00309751)

Exclusion Criteria:

  • Withdrawal from NK-104-305 (NCT00309751)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   India,   Netherlands,   Poland,   United Kingdom
 
NCT00344370
NK-104-310
No
Dragos Budinski, MD, Kowa Research Europe
Kowa Research Europe
Not Provided
Study Director: Dragos Budinski, MD Kowa Research Europe (KRE)
Kowa Research Europe
January 2010

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