Double-blind follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-blind Extension of Treatment in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 178
- Locations
- 28
- Primary Endpoint
- Number of Patients Attaining NCEP LDL-C Target at Week 16
Study Overview
Brief Summary
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.
Detailed Description
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Completed NK-104-304 (NCT 00309738)
- •Hypercholesterolemia or combined dyslipidemia
- •2 or more risk factors for coronary heart disease (CHD)
Exclusion Criteria
- •Withdrawn or terminated from NK-104-304 (00309738)
Arms & Interventions
Pitavastatin 4 mg
Pitavastatin 4 mg once daily
Intervention: pitavastatin (Drug)
Simvastatin 40mg/80mg
Simvastatin 40 mg or 80 mg once daily
Intervention: simvastatin (Drug)
Outcomes
Primary Outcomes
Number of Patients Attaining NCEP LDL-C Target at Week 16
Time Frame: 16 weeks
Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.
Number of Patients Attaining NCEP LDL-C Target at Week 44
Time Frame: 44 Weeks
Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.
Secondary Outcomes
- Percent Change From Baseline in LDL-C(Baseline to 44 weeks)