EUCTR2011-004983-32-GRActive, not recruitingNot Applicable
A 52-Week Open-Label Extension and Safety Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood, P/266/2011, P/267/2011, P/268/2011 - PASCAL402
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Kowa Research Europe, Ltd.
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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:
- •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.
Investigators
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Completed
Phase 3
A 52-Week Open-Label Extension and Safety Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood (NK-104-4.02EU).high cholesterolhyperlipidaemiahyperlipidemieNL-OMON37642Kowa Research Europe40