NL-OMON37577
Completed
Phase 3
A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, 12-Week Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood P/266/2011, P267/2011, P268/2011 - PASCAL 401
Kowa Research Europe0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- hyperlipidemie
- Sponsor
- Kowa Research Europe
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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