Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients

Kowa

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia or Combined Dyslipidemia

Treatments: Drug: Pravastatin; Drug: Pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00257686

NK-104-306

Details and patient eligibility

About

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

Full description

Following a wash-out dietary lead-in period, patients will receive either Preavastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.

Enrollment: 962 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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962 participants in 6 patient groups

Pitavastatin 1 mg

Experimental group

Description:

Pitavastatin 1 mg once daily

Treatment:

Drug: Pitavastatin

Pravastatin 10 mg

Active Comparator group

Description:

Pravastatin 10 mg once daily

Treatment:

Drug: Pravastatin

Pitavastatin 2 mg

Experimental group

Description:

Pitavastatin 2 mg once daily

Treatment:

Drug: Pitavastatin

Pravastatin 20 mg

Active Comparator group

Description:

Pravastatin 20 mg once daily

Treatment:

Drug: Pravastatin

Pitavastatin 4 mg

Experimental group

Description:

Pitavastatin 4 mg once daily

Treatment:

Drug: Pitavastatin

Pravastatin 40 mg

Active Comparator group

Description:

Pravastatin 40 mg once daily

Treatment:

Drug: Pravastatin