Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
Condition: Primary Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Pitavastatin; Atorvastatin
Intervention MeSH terms: Atorvastatin; Pitavastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 830.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: hypercholesterolemia; dyslipidemia; kowa; KRE; pitavastatin; NK-104

Summary:

      The purpose of this study is to compare the efficacy of pitavastatin with that of
      atorvastatin.
    

Eligibility criteria:

        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