EUCTR2004-002627-40-ES进行中（未招募）1 期
Efficacy, Safety, and Tolerability of Ezetimibe in Coadministration With Simvastatin in the Therapy of Adolescents With Heterozygous Familial Hypercholesterolemia - Pediatric HeFH Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 248
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Adolescent (age >=10 and <=17 years) boys and postmenarchal girls, > Tanner Stage II, body weight >40 kg, and above 10th percentile
- •2.Subjects on a diet in accordance with AAP guidelines for > 8 weeks (prior to V1) with the following:
- •A.Genotype-confirmed HeFH and LDL-C >159 mg/dL and <400 mg/dL OR
- •B.One of the following clinical criteria:
- •a)LDL-C >159 mg/dL and <400 mg/dL with a biological parent who has genotype-confirmed HeFH and a historical untreated LDL-C of >159 mg/dL
- •b)LDL-C >159 mg/dL and <400 mg/dL with a biological parent who has an untreated LDL-C of >210 mg/dL without a disorder known to cause secondary elevation of LDL-C.
- •c)LDL-C values >189 mg/dL and <400 mg/dL and a family history of hypercholesterolemia c/w autosomal dominant transmission.
- •d)LDL-C >159 mg/dL and <400 mg/dL with tendinous xanthomas, in the absence of a disorder known to cause secondary elevation of LDL-C.
- •3.Fasting TG <=350 mg/dL at Visit 1 and Visit 2.
- •4.On a diet in accordance with AAP guidelines for > 13 weeks prior to the qualifying lipid determination at Visit 2.
- •5.Liver function tests: ALT (SGPT) and AST (SGOT), must be <= 1.5 times ULN.
- •6.CPK must be < =1.5 times ULN.
- •7.Sexually active females must practice medically acceptable birth control
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
排除标准
- •Subjects diagnosed with delayed puberty.
- •Subjects with known hypersensitivity or any contraindication to simvastatin or ezetimibe.
- •Known presence of an Apo B gene mutation with confirmed absence of an LDL–receptor mutation in either allele.
- •Females pregnant, intending pregnancy, or nursing
- •History of mental instability, treatment (past or present) for severe psychiatric illness that will interfere with study participation (investigator’s discretion)
- •Excessive alcohol consumption or history of alcohol or drug abuse within the past 2 years (case by case)
- •Underlying disease limiting life span <1 year
- •Any investigational drugs within 30 days of study entry (V1?)
- •Participation in other clinical study (unless permitted by sponsor)
- •Staff or personnel directly involved with this study
- •Family members of the investigational study staff
- •Any other condition that may interfere with optimal participation in the study (investigator’s d discretion)
研究者
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