ong term investigation of Pitavastatin for high-cholesterol in childre

• Conditions: hyperlipidaemia; MedDRA version: 14.1Level: PTClassification code 10062060Term: HyperlipidaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10016205Term: Familial hyperlipidaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1Level: LLTClassification code 10057099Term: Heterozygous familial hypercholesterolaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1Level: LLTClassification code 10049593Term: Familial hypercholesterolaemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-004983-32-ES
• Lead Sponsor: Kowa Research Europe, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-28
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Male or female ?6 years of age and <17 years of age at Visit 1;
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);
? 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: 120
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;
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