Status:
COMPLETED
Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Lead Sponsor:
Kowa Research Europe
Conditions:
Hypercholesterolemia
Dyslipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.
Detailed Description
Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either pitavastatin or the comparator statin for 1 year.
Eligibility Criteria
Inclusion
- Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or NK-104-302 (NCT00309777)
- Patients who have not developed any treatment emergent and, in the opinion of the investigator, related adverse event (AE) of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin.
- Patients who have been following a fat and cholesterol restrictive diet.
Exclusion
- Any conditions which may cause secondary dyslipidemia should be reassessed at the beginning of the follow-up study.
- Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up study.
- Abnormal pancreatic, liver, or renal function
- Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the pre-specified level
- Significant heart disease
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
1355 Patients enrolled
Trial Details
Trial ID
NCT00325780
Start Date
July 1 2006
End Date
November 1 2007
Last Update
February 2 2010
Active Locations (186)
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1
Copenhagen University Hospital
Copenhagen, Denmark
2
Medical Center
Copenhagen, Denmark
3
Y Forskning, Bispebjerg Hospital
Copenhagen Nv, Denmark
4
Frederiks Hospital, Kardiologisk
Frederiksberg, Denmark