Phase 3 Completed N=355 Randomized Quadruple-blind Treatment

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Hypercholesterolemia · Dyslipidemia

Source: ClinicalTrials.gov NCT00309738 ↗

Enrolled (actual)

355

Serious AEs

—

Results posted

Jan 2010

Primary outcomePrimary: Percent Change From Baseline in LDL-C — -43.96; -43.77 mg/dL

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in LDL-C	-43.96; -43.77	—
SECONDARY Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)	203; 101	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00309738). 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.