NL-OMON39721撤回3 期
A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients with Primary Hypercholesterolemia Who are Intolerant to Statins - R727-CL-1119
Regeneron Pharmaceuticals Inc.0 个研究点目标入组 66 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with primary hypercholesterolemia (familiaal of niet familiaal) with moderate, high or very high CV risk and a history of statin intolerance
- •*** Definition of statin intolerance: Inability to tolerate at least 2 previous statins at the lowest approved daily dose due to skeletal muscle-related symptoms, other than those due to strain or trauma, such as pain, aches, weakness, or cramping, that began or increased during statin therapy and stopped when statin therapy was discontinued.
排除标准
- •- Calculated serum LDL-C <70 mg/dL (1.81 mmol/L) and very high CV risk (as defined in section 4.2) at the screening visit (week -7)
- •- Calculated serum LDL-C <100 mg/dL (2.59 mmol/L) and high or moderate CV risk (as defined in section 4.2) at the screening visit (week -7)
- •- diagnosis of fibromyalgia, history of severe neuropathic pain, history of reumatological disease, history of myalgia or myopathy, history of seizure disorder, history of transplant surgery
- •- presence of clinically significant uncontrolled endocrine disease known to influence serum lipids
- •- known loss of function of PCSK9 (genetic mutation)
- •- known homozygous FH
- •- < 18 years or legal age
- •- known HIV positivity
- •- previous participation in any clinical trial of REGN727 or SAR236553
研究者
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