Phase 3 Completed N=857 Randomized Triple-blind Treatment

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Hypercholesterolemia · Dyslipidemia

Source: ClinicalTrials.gov NCT00309777 ↗

Enrolled (actual)

857

Serious AEs

1.3%

Results posted

Dec 2009

Primary outcomePrimary: Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks — -38.99; -34.97; -43.97; -42.84 Percent change

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks	-38.99; -34.97; -43.97; -42.84	—
SECONDARY National Cholesterol Education Program (NCEP) LDL-C Target Attainment	215; 69; 253; 86	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00309777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.