Phase 3 Completed N=1,355 Treatment

Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Hypercholesterolemia · Dyslipidemia

Source: ClinicalTrials.gov NCT00325780 ↗

Enrolled (actual)

1,355

Serious AEs

3.6%

Results posted

Jan 2010

Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) — -42.89 percent change

Summary

This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)	-42.89	—
SECONDARY Change From Baseline in Total Cholesterol	-29.59	—

Eligibility Criteria

Inclusion Criteria

Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or NK-104-302 (NCT00309777)
Patients who have not developed any treatment emergent and, in the opinion of the investigator, related adverse event (AE) of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin.
Patients who have been following a fat and cholesterol restrictive diet.

Exclusion Criteria

Any conditions which may cause secondary dyslipidemia should be reassessed at the beginning of the follow-up study.
Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up study.
Abnormal pancreatic, liver, or renal function
Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the pre-specified level
Significant heart disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00325780). 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.