high-risk hyperlipidaemia MedDRA version: 14.1 Level: PT Classification code 10062060 Term: Hyperlipidaemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: PT Classification code 10020603 Term: Hypercholesterolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: LLT Classification code 10016205 Term: Familial hyperlipidaemia System Organ Class: 10010331 - Congenital, familial and genetic disorders Me
Conditions
Interventions
Trade Name: Livazo 1 mg film-coated tablets
Product Name: Pitavastatin
Product Code: NK 104
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Pitavastatin
CAS Number: 147526-32-7
Current Sp
Sponsors
Kowa Research Europe, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female =6 years of age and 150 mg/dL); • Presence of high lipoprotein(a) (>75 nmol/L); 09 December 2011 vii12 • Presence of type 2 diabetes mellitus diagnosed by treating physician according to current guidances; or • Presence of hypertension defined as systolic and diastolic blood pressures above the 95th percentile for age and size; 3. Have not taken any lipid-lowering medications in the 5 weeks prior to screening or in the 4 weeks prior to the lipid qualifying visit at Week -1; 4. Have been adherent to an appropriate diet for at least 8 weeks; 5. Females who are post-menarche must not be pregnant or breast feeding and, if sexually active, must be using a reliable form of contraception; and 6. Written informed consent and assent (if necessary) obtained as required per local regulations. Are the trial subjects under 18? yes Number of subjects for this age range: 96 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to take study drug; 2. Fasting TG >400 mg/dL (4.5 mmol/L); 3. Homozygous familial hypercholesterolaemia; 4. Other secondary causes of hyperlipidaemia (eg, hypothyroidism, human immunodeficiency virus infection, systemic lupus erythematosus, organ transplantation, previous malignancy, nephrotic syndrome, glycogen storage disease); 5. Previous history of statin intolerance, adverse effects with other statin use, or hypersensitivity to any components of the study drug; 6. Need for non-statin lipid-lowering medications; 7. Apheresis therapy; 8. Use of any concomitant medication which may interfere with the objectives of the study; 9. Type 1 diabetes mellitus; 10. Poorly controlled type 2 diabetes mellitus defined as haemoglobin A1c >9.0% at screening; 11. Severe renal impairment defined as serum creatinine >2.0 mg/dL at screening; 12. Uncontrolled hypertension; 13. Untreated thyroid disease; 14. Severe hepatic impairment, active liver disease, or persistent elevation of alanine transaminase or aspartate transaminase >3 × the upper limit of normal (ULN); 15. Active muscle disease or creatine kinase >3 × ULN (unless explained by exercise); 16. Screening laboratory values within the following age/gender appropriate reference ranges as assessed by the central laboratory: • Haemoglobin 2 × ULN for age; 17. Any other laboratory abnormality that could compromise patient safety because of study participation; 18. Malignancy during the past 5 years; 19. Current smoker or history of drug or alcohol abuse; 20. Hospitalisation for any cause within 30 days prior to the administration of study drug; 21. History of major surgery in the 3 months prior to screening; 22. Any medical condition which, in the judgment of the Investigator, would jeopardize the evaluation of safety and/or constitute a significant safety risk to the patient; or 23. Participation in another clinical study involving an investigational drug during the course of this study or within 30 days prior to signing the informed consent/assent form for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of pitavastatin 1 mg QD, 2 mg QD, and 4 mg QD to placebo in terms of the percentage reduction in LDL-C in children or adolescent patients with high-risk hyperlipidaemia at steady state (Week 12).;Secondary Objective: The secondary objectives of this study are the following: • To compare the efficacy of pitavastatin 1 mg QD, 2 mg QD, and 4 mg QD to placebo in terms of the change or percent change in secondary lipid parameters in children and adolescent patients with high-risk hyperlipidaemia over 12 weeks; • To measure PK parameters at each dose level; and • To compare the safety and tolerability of pitavastatin 1 mg QD, 2 mg QD, and 4 mg QD to placebo in children and adolescent patients with high-risk hyperlipidaemia over 12 weeks.;Primary end point(s): The primary efficacy endpoint of this study is the percent change in LDL-C from baseline to Week 12 endpoint.;Timepoint(s) of evaluation of this end point: see above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percent change in LDL-C from baseline over 12 weeks of treatment (Week 4, Week 8, and Week 12); • Percentages of patients who achieve AHA minimal (130 mg/dL [3.4 mmol/L]) and ideal (110 mg/dL [2.8 mmol/L]) LDL-C targets over 12 weeks of treatment; • Percent changes in HDL-C, non-high-density lipoprotein cholesterol (non-HDL-C), TC, TG, apolipoprotein A1 (Apo A1), and Apo B from baseline over 12 weeks of treatment; and • Changes in TC:HDL-C ratio, non-HDL-C:HDL-C ratio, and Apo B:Apo A1 ratio from baseline over 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: see above | — |
Countries
Greece, Italy, Netherlands, Norway, Spain
Contacts
Public ContactRegulatory Affairs
Kowa Research Europe Co, Ltd.
Outcome results
None listed