Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients
Condition: Hypercholesterolemia or Combined Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Pitavastatin; Pravastatin
Intervention MeSH terms: Pravastatin; Pitavastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 962.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Kowa; Hypercholesterolemia; combined; dyslipidemia; elderly; pitavastatin; NK-104

Summary:

      The purpose of this study is to compare the efficacy and safety of pitavastatin with that of
      pravastatin in elderly patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and postmenopausal females (aged 65 years and older

          -  Eligible, able to participate, have given informed consent

          -  Must have been following a restrictive diet

          -  Diagnosis of primary hypercholesterolemia or combined dyslipidemia

          -  Serum CK must be less than or equal to 1.5 x ULRR at 2 of 3 permitted evaluations
             between Week -4 and -1

          -  Agree to be available

        Exclusion Criteria

          -  Homozygous familial hypercholesterolemia

          -  Conditions which may cause secondary dyslipidemia

          -  Uncontrolled diabetes mellitus (HbA1c >8%).

          -  Any 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

          -  Serum CK >5 x ULRR without clinical explanation

          -  Uncontrolled hypothyroidism defined as TSH >ULRR

          -  Any severe acute illness or severe trauma in the last 3 months prior to Visit 1

          -  Major surgery, 3 months prior to Visit 1

          -  Significant 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 ejection fraction <0.25;

          -  History of symptomatic cerebrovascular disease

          -  Any other conditions at the discretion of the investigator

          -  Known HIV infection

          -  Poorly controlled or uncontrolled hypertension

          -  Prior or current 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

          -  History of hypersensitivity 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

          -  Any factor which makes regular clinic attendance in the morning impractical ---Signs
             of mental dysfunction or other factors likely to limit ability to cooperate with the
             study.