Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kowa Research Europe
• Treatments: Pitavastatin; Simvastatin

Criteria

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