Status:
COMPLETED
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
Lead Sponsor:
Kowa Research Europe
Conditions:
Hypercholesterolemia
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 simvastatin in patients with risk factors for heart disease.
Eligibility Criteria
Inclusion
- Males and females (18-75 years of age)
- At least two cardiovascular disease risk factors
- Must have been following a restrictive diet
- Diagnosis of primary hypercholesterolemia or 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT00309738
Start Date
September 1 2005
End Date
October 1 2006
Last Update
March 16 2010
Active Locations (35)
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1
CCBR A/S
Aalborg, Denmark
2
CCBR A/S
Ballerup Municipality, Denmark
3
Y Forskning, Bispebjerg Hospital
Copenhagen NV, Denmark
4
Frederiks Hospital, Kardiologisk
Frederiksberg, Denmark