ong term investigation of Pitavastatin for high-cholesterol in childre

Conditions: hyperlipidaemia
MedDRA version: 15.0Level: 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: EUCTR2011-004983-32-IT

Lead Sponsor: KOWA RESEARCH EUROPE LTD

Brief Summary: Not available

Detailed Description: Not available

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.