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

Kowa

Status and phase

Completed

Phase 3

Conditions

Primary Hypercholesterolemia

Dyslipidemia

Treatments

Drug: Pitavastatin

Drug: Atorvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00249249

NK-104-301

EudraCT number 2005-001000-39

Details and patient eligibility

About

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

Full 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.

Enrollment

830 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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