Trial | NCT00309738  Report issue

Title

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Study Participants

    355
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.
Study Started
Sep 30
2005
Primary Completion
Oct 31
2006
Study Completion
Oct 31
2006
Results Posted
Jan 18
2010
Estimate
Last Update
Mar 16
2010
Estimate

Drug pitavastatin

Drug simvastatin

Pitavastatin 4 mg QD Experimental

Pitavastatin 4 mg once daily

Simvastatin 40 mg QD Active Comparator

Simvastatin 40 mg once daily

Criteria 

Inclusion Criteria:

Males and females (18-75 years of age)
At least two cardiovascular disease risk factors
Must have been following a restrictive diet
Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

Homozygous familial hypercholesterolemia
Conditions which may cause secondary dyslipidemia
Uncontrolled diabetes mellitus
Abnormal pancreatic, liver or renal function
Abnormal serum creatine kinase (CK) above the pre-specified level

Summary

Pitavastatin 4 mg QD

Simvastatin 40 mg QD

All Events

Event Type Organ System Event Term Pitavastatin 4 mg QD Simvastatin 40 mg QD

Percent Change From Baseline in LDL-C

Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Pitavastatin 4 mg QD

-43.96
mg/dL (Mean)
Standard Deviation: 12.770

Simvastatin 40 mg QD

-43.77
mg/dL (Mean)
Standard Deviation: 14.416

Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)

Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL)

Pitavastatin 4 mg QD

203.0
participants

Simvastatin 40 mg QD

101.0
participants

Total

352
Participants

Age Continuous

60.3
years (Mean)
Standard Deviation: 6.81

Age, Categorical

Sex: Female, Male

Overall Study

Pitavastatin 4 mg QD

Simvastatin 40 mg QD