Combined Dyslipidemia and Type II Diabetes Mellitus MedDRA version: 8.1 Level: LLT Classification code 10058110
Conditions
Interventions
Product Name: Pitavastatin
Product Code: NK-104
Pharmaceutical Form: Tablet
INN or Proposed INN: Pitavastatin
CAS Number: 147526-32-7
Current Sponsor code: NK-104
Concentration unit: mg milligram(s)
C
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-104-305). As participants in Study NK 104 305, patients have previously received pitavastatin (at 2 mg up-titrated to 4 mg QD after 4 weeks) or a comparator (atorvastatin 10 mg up-titrated to 20 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-104-305) 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-104-305).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess long-term safety and tolerability of pitavastatin 4 mg QD. To assess the efficacy of pitavastatin (4 mg) and atorvastatin (20 mg and 40 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 atorvastatin only.;Secondary Objective: To assess the efficacy of pitavastatin (4 mg QD) and atorvastatin (20 mg, and 40 mg QD) on LDL-C levels and on other lipid and lipoprotein fractions (TC, HDL-C, TC: HDL-C ratio, TG, apolipoprotein A1 and B [Apo A1 and Apo-B], Apo-B:ApoA1 ratio, high sensitivity C reactive protein (hs CRP), adiponectin, small-dense LDL, remnant-like-particle cholesterol [RLP-C], non HDL-HDL ratio and oxidized LDL).;Primary end point(s): The long-term safety and tolerability of pitavastatin 4 mg QD will be assessed. The efficacy of pitavastatin (4 mg) and atorvastatin (20 mg and 40 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 atorvastatin only, will be assessed. | — |
Countries
Denmark, Germany, United Kingdom
Outcome results
None listed