Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels

Phase 3

Completed

Conditions: Primary Hypercholesterolemia
Dyslipidemia

Registration Number: NCT00249249

Lead Sponsor: Kowa Research Europe

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 levels.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 830

Inclusion Criteria

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 Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12	Baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Cholesterol (TC)	Baseline to 12 Weeks	Percent change in total cholesterol from baseline to Week 12
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)	Baseline to 12 weeks	percent change from baseline in high density lipoprotein-cholesterol (HDL-C)
TC:HDL-C Ratio	12 weeks	Ratio of mean total cholesterol to mean HDL-C at 12 weeks
Triglycerides (TG)	12 weeks	mean triglycerides at 12 weeks
Non-HDL:HDL Ratio	12 weeks	Ratio of non-HDL to HDL at 12 weeks
Apolipoprotein B (Apo B)	12 weeks	Apolipoprotein B at 12 weeks
Apolipoprotein-A1 (Apo-A1)	12 weeks	Apolipoprotein-A1 at 12 weeks
Apo-B:Apo-A1 Ratio	12 weeks	Ratio of Apo-B to Apo-A1 at 12 weeks
High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks	12 weeks	high sensitivity C-reactive protein (hs-CRP) at 12 weeks
Oxidized LDL at 12 Weeks	12 weeks	oxidized low density lipoprotein at 12 weeks
National Cholesterol Education Program [NCEP]LDL-C Target Attainment	up to 12 weeks	Number of patients achieving NCEP LDL-C target (LDL-C less than or equal to 130 mg/dL)

Trial Locations

Locations (190): Y Forskning, Bispebjerg Hospital
🇩🇰
Copenhagen Nv, Denmark
Copenhagen University Hospital
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Copenhagen, Denmark
Medical Center
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Copenhagen, Denmark
Frederiks Hospital, Kardiologisk
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Frederiksberg, Denmark
Kolesterollaboratoriet
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Hellerup, Denmark
CCBR A/S
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Vejle, Denmark
Geri-Med Oy
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Helsinki, Finland
Kaisaniemen Laakariasema
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Helsinki, Finland
keravan Laakarikeskus
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Helsinki, Finland
SOK-tyoterveyshuolto
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Tampere, Finland
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Y Forskning, Bispebjerg Hospital
🇩🇰Copenhagen Nv, Denmark