A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety and Pharmacodynamics of ISIS 301012 in Hypercholesterolemic Subjects on Stable Statin Therapy

Kastle Therapeutics, LLC0 个研究点目标入组 74 人开始时间: 2005年9月最近更新: 2016年8月3日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Kastle Therapeutics, LLC
入组人数: 74
主要终点: Percent reduction in LDL-cholesterol from baseline

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记录与标识符相似试验

研究概览

简要总结

The aim of this study is to assess the safety of varying doses of ISIS 301012 in subjects on Stable statin therapy.

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: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•On a stable dose of >/= 40 mg Simvastatin or atorvastatin daily for >/= 3 months prior to baseline and expected to remain on this dose for the remainder of the study
•LDL-cholesterol between 2.60 and 5.70 mmol/L (100 and 220 mg/dL), inclusive at screening
•Females not of childbearing potential.

排除标准

•History of CHD or CHD-equivalent (such as diabetes mellitus, or another clinical form of atherosclerotic disease, e.g., peripheral arterial disease, abdominal aortic aneurysm, or symptomatic carotid artery disease)
•Fasting triglyceride >2.26 mmol/L (200 mg/dL) at screening
•Any uncontrolled medical/surgical/psychiatric condition, including conditions that may predispose to secondary hypercholesterolemia
•Current diagnosis or known history of complement deficiency or abnormality
•A positive hepatitis B surface antigen or hepatitis C antibody, or a known positive HIV status
•Current diagnosis or known history of liver disease, or has an ALT >ULN at screening
•Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or has a CPK >ULN at screening
•Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin that has been adequately treated
•The advisability of a subject taking any prescription medication (apart from simvastatin or atorvastatin) within 6 weeks prior to screening should be discussed with the Isis Medical Monitor
•Subject unwilling to discontinue taking alternative/herbal medication for the duration of the study
•History of drug abuse within 2 years of screening
•Subject unwilling to limit alcohol consumption for the duration of the study: male subjects to a maximum of 3 drinks (30 g) per day, and <12 drinks (120 g) per week; female subjects to a maximum of 2 drinks (20 g) per day, and <8 drinks (80 g) per week
•Known allergy or hypersensitivity to simvastatin
•Undergoing or has undergone treatment with another investigational drug, biologic agent, or device within 3 months, or 3 half lives, prior to screening, whichever is longer