Status:
COMPLETED
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
Lead Sponsor:
Kowa Research Europe
Conditions:
Primary Hypercholesterolemia
Dyslipidemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.
Detailed Description
Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol level...
Eligibility Criteria
Inclusion
- Males and females (age 18-75 years).
- Non-pregnant, non-lactating females
- Women of child bearing potential should use sustained contraceptive preparations or an approved mechanical contraceptive method.
- Eligible and able to participate and have given informed consent
- Must have been following a restrictive diet and does not eat or drink grapefruit
- Diagnosis of primary hypercholesterolemia or combined dyslipidemia
- Available for every clinic visit, which will occur in the morning.
Exclusion
- Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia
- Conditions which may cause secondary dyslipidemia.
- Condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
- History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
- Liver injury
- Impaired renal function
- Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator
- Serum creatine kinase (CK) \>5 x upper limit of the reference range (ULRR).
- Uncontrolled hypothyroidism
- Severe acute illness or severe trauma in the last 3 months
- Major surgery, 3 months prior to Visit 1
- Significant cardiovascular disease (CVD) prior to randomization
- Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of \>100 beats per minute at rest.
- Left ventricular (LV) ejection fraction \< 0.25
- History of symptomatic cerebrovascular disease
- Conditions at the discretion of the investigator
- Known HIV infection
- Poorly controlled or uncontrolled hypertension.
- Known muscular or neuromuscular disease of any type
- Neoplastic disease
- Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
- Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
- Current or recent use of supplements known to alter lipid metabolism
- Hypersensitivity reactions to other HMG-CoA reductase inhibitors
- Concomitant medication not permitted
- Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
- Excessive obesity
- Regular clinic attendance in the morning impractical
- Signs of mental dysfunction or other factors likely to limit ability to cooperate
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
830 Patients enrolled
Trial Details
Trial ID
NCT00249249
Start Date
October 1 2005
End Date
November 1 2006
Last Update
January 12 2010
Active Locations (192)
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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