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临床试验/NCT02956590
NCT02956590已完成3 期

Dyslipidemia of Obesity Intervention in Teens Trial

Carelon Research16 个研究点 分布在 2 个国家目标入组 122 人开始时间: 2018年5月1日最近更新:
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适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
122
试验地点
16
主要终点
the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity (CDO)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial of pitavastatin will determine efficacy and safety in this high risk population and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.

详细描述

Randomized, double-blind, placebo-controlled clinical trial of pitavastatin for 2 years comparing the effect of study drug versus placebo on vascular measures in at least 354 adolescents with excess adiposity and CDO (defined as high non-HDL-C + high triglycerides (TG)/HDL-C ratio or low HDL-C). Enrollment will take place over 36 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 19 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Boys and girls aged 10 to 19 years (with 2-year availability for study participation)
  • •BMI ≥85th percentile (using Centers for Disease Control (CDC) BMI charts)
  • •Fasting lipid profile x2 each with all of the following:
  • •LDL-C <160 mg/dL and ≥90 mg/dL, and
  • •TG (triglycerides) <500 mg/dL, and
  • •TG/HDL-C ratio ≥2.5 or HDL-C <45 mg/dL for boys or HDL-C <50 mg/dL for girls, and
  • •non-HDL-C ≥120 mg/dL
  • •Participant consent, or parental/guardian consent and participant assent

排除标准

  • •Current use of lipid lowering medication, growth hormone, systemic corticosteroids, cyclosporine, protease inhibitors, erythromycin, rifampin, colchicine, warfarin, second generation psychotropic drugs, oral isotretinoin; stable doses of stimulant or antidepressant therapy and antihypertensive medications will be accepted
  • •Known allergy or hypersensitivity to statin
  • •Patients who have had bariatric surgery or plan to have bariatric surgery during the trial
  • •Female who is pregnant, plans to become pregnant or is sexually active without contraception
  • •Uncontrolled stage 2 hypertension (systolic or diastolic blood pressure ≥95th percentile for age, sex and height percentile + 12 mmHg or ≥140/90, whichever is lower for participants <13 years of age; ≥140/90 for participants ≥13 years of age) confirmed after an appropriate evaluation
  • •Diabetes (type 1 or type 2) by American Diabetes Association criteria (fasting glucose ≥126 mg/dL, HbA1c ≥6.5%, random glucose ≥200 mg/dL, or 2-hour oral glucose tolerance testing glucose ≥200 mg/dL)
  • •Use of insulin sensitizing therapy
  • •Known renal insufficiency (known chronic renal disease, estimated glomerular filtration rate (GFR) <60 mL/min/1.73m2 at screening)
  • •Uncontrolled thyroid disease (TSH at screening >1.5x upper limit of normal, clinical or other laboratory evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for 6 weeks prior to screening)
  • •Proteinuria suggestive of renal disease (more than trace together with an elevated urine protein:creatinine ratio as per local lab)
  • •Syndromic patients or patients with neurocognitive delay precluding adherence with study drug
  • •Liver disease other than non-alcoholic fatty liver disease (NAFLD) either diagnosed or suggested by alanine aminotransferase (ALT) ≥ 40 U/L, or severe NAFLD indicated by ALT ≥ 200 U/L
  • •Unexplained persistent elevated creatine kinase (CK) level >3x upper limit of normal
  • •Plans to leave the geographic area before completion of the anticipated 2 years of trial participation
  • •Any unstable medical or emotional condition or chronic disease that would preclude following the protocol or impact valid vascular measurement
  • •Admits to current smoking, current alcohol consumption

研究组 & 干预措施

Pitavastatin

Active Comparator

Study Drug

干预措施: Pitavastatin (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity (CDO)

时间窗: 2 years

Pulse wave velocity (PWV)

次要结局

  • the effect of pitavastatin versus placebo on Standard Fasting Lipid Profile (FLP)(2 years)
  • the effect of pitavastatin versus placebo on vascular measures in obese adolescents with combined dyslipidemia of obesity (CDO)(2 years)
  • the effect of pitavastatin versus placebo on prevalence of abnormal creatinine kinase (CK) tests(2 years)
  • the effect of pitavastatin versus placebo on Nuclear magnetic resonance (NMR) Spectroscopy Lipoprotein Particle Assessment(2 years)
  • the effect of pitavastatin versus placebo on prevalence of adverse events.(2 years)
  • the effect of pitavastatin versus placebo on composite outcome of Number of Participants With Abnormal Laboratory Values and/or Adverse Events(2 years)
  • the effect of pitavastatin versus placebo on prevalence of abnormal changes in height(2 years)
  • the effect of pitavastatin versus placebo on vascular measures in at least 354 obese adolescents with combined dyslipidemia of obesity(2 years)
  • the effect of pitavastatin versus placebo on lipid measures(2 years)
  • the effect of pitavastatin versus placebo on prevalence of abnormal Liver function tests (ALT, AST)(2 years)
  • the effect of pitavastatin versus placebo on composite outcome of markers of glycemic control/development of diabetes(2 years)
  • the effect of pitavastatin versus placebo on composite outcome of abnormal change in surrogate markers of insulin sensitivity(2 years)

研究者

发起方
Carelon Research
申办方类型
Other
责任方
Sponsor

研究点 (16)

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