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.
Eligibility Criteria
Inclusion
- Males and females (18-75 years)
- Must have been following a restrictive diet
- Diagnosis of primary hypercholesterolemia or combined dyslipidemia
Exclusion
- Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
- Conditions which may cause secondary dyslipidemia.
- Uncontrolled diabetes mellitus (by hemoglobin A1c \[HbA1c\] \> 8%)
- Abnormal serum creatine kinase (CK) above the pre-specified level
- Abnormal pancreatic, liver or renal function
- Significant heart disease
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
857 Patients enrolled
Trial Details
Trial ID
NCT00309777
Start Date
September 1 2005
End Date
October 1 2006
Last Update
January 12 2010
Active Locations (42)
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1
Geri-Med Oy
Helsinki, Finland
2
Kaisaniemen Laakariasema
Helsinki, Finland
3
Keravan Laakarikeskus
Helsinki, Finland
4
SOK-tyoterveyshuolto
Tampere, Finland