PRIMARY HYPERCHOLESTEROLEMIA OR COMBINED DYSLIPIDEMIA MedDRA version: 7.1 Level: LLT Classification code 10020604
Conditions
Sponsors
Kowa Research Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and postmenopausal females (aged 65 years and older); 2. Patients who are eligible and able to participate in the study and who have given informed consent after the purpose and nature of the investigation has been explained to them; 3. In order to qualify for randomization, patients must have been following a fat and cholesterol restrictive diet as advised by the EAS during the dietary stabilization lead-in period (i.e., for at least 8 weeks for those patients previously taking lipid lowering medication and at least 6 weeks for those not previously taking lipid lowering medication). Patients must also agree not to eat grapefruit or drink grapefruit juice for the duration of the study; 4. In order to qualify for randomization at Visit 4 (Week 0), patients must present with primary hypercholesterolemia or combined dyslipidemia, as defined by elevated plasma LDL C [LDL C =3.4 mmol/L (130 mg/dL) =5.7 mmol/L (220 mg/dL)] despite dietary therapy and elevated TG levels of =4.6 mmol/L (400 mg/dL) at 2 visits during the dietary lead-in period. If these criteria are not satisfied at Visit 2 (Week –2) and Visit 3 (Week –1), or if the LDL C concentration of the lower qualifying specimen differs by =15% from the higher qualifying specimen, 1 additional lipid sample will be permitted for both variables 1 week after Visit 3 (Visit 3A) to enable the patient to qualify for randomization; 5. Serum CK must be =1.5 x ULRR at all permitted evaluations between Week -8/-6 (Visit 1) and -1 (Visit 3) for the patient to be eligible for further study participation. However if at any visit during the screening period (Visit 1-3) serum CK is between 1.5 and 5 x ULRR a re-test will be allowed. In cases when the repeat CK is >1.5 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Homozygous familial hypercholesterolemia (heterozygous component of familial hypercholesterolemia is acceptable for inclusion); 2. Any conditions which may cause secondary dyslipidemia. 3. Uncontrolled diabetes mellitus 4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. 5. Any history of pancreatic injury or pancreatitis, or impaired pancreatic function/injury as indicated by abnormal lipase or amylase; 6. Liver injury 7. Impaired renal function 8. Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator; 9. Serum CK > 5 x ULRR. If at any visit during the screening period (Visit 1-3) serum CK is between 1.5 and 5 x ULRR a re-test will be allowed. If the repeat CK is >1.5 and 1.5 and ULRR. 11. Any severe acute illness or severe trauma in the last 3 months prior to Visit 1 (Week -8/-6); 12. Major surgery, during the 3 months prior to Visit 1 (Week -8/-6); 13. Significant CVD prior to randomization, such as myocardial infarction, coronary or peripheral artery angioplasty, bypass graft surgery or severe or unstable angina pectoris; 14. Evidence of symptomatic heart failure (New York Heart Association [NYHA] class III or IV), gross cardiac enlargement (cardiothoracic ratio >0.5); significant heart block or cardiac arrhythmias. 15. Left ventricular (LV) ejection fraction 10 years. Patients with prior history of basal cell carcinoma or squamous cell carcinoma of the skin re
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of pitavastatin 1 mg once daily (QD) versus (vs.) pravastatin 10 mg QD, pitavastatin 2 mg QD vs. pravastatin 20 mg QD, and pitavastatin 4 mg QD vs. pravastatin 40 mg QD with respect to the reduction of LDL-C, when administered for 12 weeks using an up-titration regimen for the highest doses (i.e., 4 mg pitavastatin and 40 mg pravastatin).;Secondary Objective: To compare the efficacy of pitavastatin 1 mg QD vs. pravastatin 10 mg QD; pitavastatin 2 mg QD vs. pravastatin 20 mg, and pitavastatin 4 mg QD vs. pravastatin 40 mg QD with respect to changes from baseline in other lipid and lipoprotein fractions (TC, HDL C, TC:HDL-C ratio, non-HDL:HDL ratio, TG, Apo B and apolipoprotein A1 [Apo-A1], Apo-B:Apo-A1 ratio, high sensitivity C-reactive protein (hs-CRP), oxidized LDL, and LDL-C target attainment [European Atherosclerosis Society {EAS}, and National Cholesterol Education Program {NCEP}]); andTo assess the safety and tolerability of pitavastatin 1 mg QD, 2 mg QD, and 4 mg QD when administered for 12 weeks using an up-titration regimen for the highest dose (i.e., 4 mg pitavastatin).;Primary end point(s): To demonstrate the non-inferiority of pitavastatin 1 mg once daily (QD) versus (vs.) pravastatin 10 mg QD, pitavastatin 2 mg QD vs. pravastatin 20 mg QD, and pitavastatin 4 mg QD vs. pravastatin 40 mg QD. | — |
Countries
Denmark, Germany, United Kingdom
Outcome results
None listed