Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease MedDRA version: 8.1 Level: LLT Classification code 10020604
Conditions
Sponsors
Kowa Research Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients entering this study must have satisfied inclusion/exclusion criteria for the previous core study (NK-104-304). As participants in Study NK-104-304, patients have previously received pitavastatin (at 2 mg up-titrated to 4 mg QD after 4 weeks) or a comparator (simvastatin 20 mg up-titrated to 40 mg QD after 4 weeks) for a total of 12 weeks and followed a diet according to EAS guidelines (Appendix A) for 18 to 20 weeks. To be eligible for participation in this study the patients must have completed 12 weeks of active treatment in the core study (NK-104-304) and continue to follow the diet according to EAS guidelines. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: All patients entering this study must have satisfied inclusion/exclusion criteria for the previous core study (NK-104-304).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy variable is the proportion of patients attaining the LDL-C target goal at Visit 4 (Week 16) for the 16 week double-blind treatment period and at Visit 8 (Week 44) for the 28 week single-blind treatment period. ; Main Objective: To assess long-term safety and tolerability of pitavastatin 4 mg QD. To assess the efficacy of pitavastatin (4 mg) and simvastatin (40 mg and 80 mg QD) in terms of LDL-C target attainment (European Atherosclerosis Society [EAS] and National Cholesterol Education Program [NCEP]) following 16 weeks and 44 weeks of treatment in this study (equivalent to 24 and 52 weeks total 4 mg pitavastatin treatment, respectively) using an up-titration regimen for simvastatin only. ;Secondary Objective: To assess the efficacy of pitavastatin (4 mg QD) and simvastatin(40 mg and 80 mg) on LDL-C levels and on other lipid and lipoprotein fractions (TC, HDL-C, TC:HDL-C ratio, TG, non-HDL:HDL ratio, apolipoprotein A1 and B [Apo-A1 and Apo-B], Apo-B:Apo-A1 ratio, high sensitivity C-reactive protein (hs-CRP) and oxidized LDL. | — |
Countries
Denmark, Spain, Sweden, United Kingdom
Outcome results
None listed