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

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.

Detailed Description
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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.

Official Title
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Study of Pitavastatin 2 mg vs. Atorvastatin 10 mg and Pitavastatin 4 mg vs. Atorvastatin 20 mg (Following Up Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Conditions
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Dyslipidemia, Primary Hypercholesterolemia

Intervention / Treatment
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* Drug: Pitavastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pitavastatin|nan|
|Drug: Atorvastatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12 |  | Baseline to 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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KRE, hypercholesterolemia, dyslipidemia, kowa, pitavastatin, NK-104