Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Kowa

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia; Dyslipidemia

Treatments: Drug: Pitavastatin; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00309777

NK-104-302

EudraCT number 2005-001033-15

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.

Enrollment: 857 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females (18-75 years)
• Must have been following a restrictive diet
• Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion criteria

• Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
• Conditions which may cause secondary dyslipidemia.
• Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%)
• Abnormal serum creatine kinase (CK) above the pre-specified level
• Abnormal pancreatic, liver or renal function
• Significant heart disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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857 participants in 4 patient groups

Pitavastatin 2 mg

Experimental group

Description:

Pitavastatin 2 mg once daily

Treatment:

Drug: Pitavastatin

Simvastatin 20 mg

Active Comparator group

Description:

Simvastatin 20 mg once daily

Treatment:

Drug: Simvastatin

Pitavastatin 4 mg

Experimental group

Description:

Pitavastatin 4 mg once daily

Treatment:

Drug: Pitavastatin

Simvastatin 40 mg

Active Comparator group

Description:

Simvastatn 40 mg once daily

Treatment:

Drug: Simvastatin