EUCTR2012-002434-37-IT进行中（未招募）1 期
A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-WeekStudy to Assess the Efficacy and Tolerability of Anacetrapib When Added to OngoingLipid-Lowering Therapy in Adult Patients with Homozygous FamilialHypercholesterolemia (HoFH) - n.a.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 45 人开始时间: 2013年6月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- 性别
- All
入选标准
- •-Patient is male or female and = 18 years of age on day of signing informed consent.
- •-Patient is diagnosed with HoFH by genotyping as defined by documented mutations causing familial hypercholesterolemia in both alleles of LDLR including, but not limited to a LDLR null mutation.
- •-Patients have been stabilized on statin monotherapy or statin therapy coadministered with other lipid medications for at least 6 weeks prior to randomization along with adequate stabilization of LDL apheresis regimen for at least 8 weeks prior to randomization. A new lipid-modifying therapy or apheresis regimen should not be initiated during the first 12 weeks after randomization.
- •-Patient provides written informed consent/assent for the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •-Patient has a triglyceride value >400 mg/dL (6.78 mmol/L), creatine kinase (CK) >2x upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) [per central laboratory reference ranges].
- •-Patient has severe chronic heart failure defined by New York Heart Association (NYHA) Classes III or IV or uncontrolled cardiac arrhythmias, MI, PCI, CABG, unstable angina or stroke within 3 months prior to Visit 1 or has planned procedures scheduled during the first 12-weeks of the study.
- •-Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, thyroid stimulating hormone (TSH) values outside the central laboratory normal ranges or chronic hepatobiliary or gall bladder disease.
- •-Patient has eGFR <30 mL/min/1.73m2 based on 4-variable MDRD equation, nephrotic syndrome or other clinically significant renal disease.
- •-Patient has history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption.
- •-Patient is human immunodeficiency virus (HIV) positive.
- •- Patient has donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent (excluding apheresis), or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study.
- •- Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
- •-Patient is currently taking medications that are potent inhibitors or inducers of CYP3A4 or has discontinued treatment <3 weeks prior to Visit 1. Consumption of >1 liter of grapefruit juice per day is also prohibited.
- •-Patient is currently participating or has participated in a study with an investigational compound or device within 3 months of signing informed consent.
- •-Patient consumes more than 2 alcoholic drinks per day.
- •- Patient is receiving treatment with systemic corticosteroids or systemic anabolic agents.
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