Status:
COMPLETED
Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Lead Sponsor:
Kowa Research Europe
Conditions:
Type II Diabetes Mellitus
Dyslipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
418 Patients enrolled
Trial Details
Trial ID
NCT00309751
Start Date
December 1 2005
End Date
June 1 2007
Last Update
February 23 2010
Active Locations (35)
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1
CCBR Aalborg
Aalborg, Denmark
2
CCBR A/S
Ballerup Municipality, Denmark
3
CCBR Vejle
Vejle, Denmark
4
Gemeinschaftspraxis am Bahnhof
Berlin-Spandau, Germany