Investigating Pitavastatin for High Cholesterol in Childre

• Conditions: high-risk hyperlipidaemia; MedDRA version: 14.1Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-004964-32-IT
• Lead Sponsor: KOWA RESEARCH EUROPE LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-02
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Male or female =6 years of age and <17 years of age at randomisation; 2. Have fasting LDL-C levels =160 mg/dL (4.1 mmol/L) or LDL-C =130 mg/dL (3.4 mmol/L) if any of the following additional risk factors are present: • Male; • A family history of premature cardiovascular disease defined as a myocardial infarction before age 50 in a second-degree relative or before age 60 in a first-degree relative with at least 1 relative (parent, grandparent, or sibling) affected; • Presence of low HDL-C (<45 mg/dL) or high TG (>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: 100
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

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 <10 g/dL for males or <9 g/dL for females or • Alkaline phosphatase >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; XML File Identifier: dNw0wtR8rmqExPqLUwPkY9jjWwc= Page 20/34 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified