NCT02571257已完成2 期
An 8-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study in Hypercholesterolemic Patients to Determine the Efficacy and Safety of Combination Therapy With CI-1027 and a Statin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- LDL-C - percent change from baseline at Week 8
研究概览
简要总结
The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.
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
- •Males and Females
- •18 to 65 years of age
- •Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)
排除标准
- •If female, postmenopausal or surgically menopausal
- •Triglycerides (TG) >400 mg/dL
- •Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
- •Body Mass Index (BMI) >35 kg/m2
- •Uncontrolled diabetes mellitus (HbA1c >10%)
- •Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN)
- •Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN)
- •Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month
研究组 & 干预措施
Gemcabene 900 mg QD
Experimental
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
干预措施: Gemcabene (Drug)
Placebo
Placebo Comparator
Placebo treatment on stable background statin therapy
干预措施: Placebo (Drug)
Gemcabene 300 mg QD
Experimental
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
干预措施: Gemcabene (Drug)
结局指标
主要结局
LDL-C - percent change from baseline at Week 8
时间窗: 56 days
次要结局
- Clinical Laboratory(56 days)
- Plasma lipid levels - percent change from baseline at Week 8(56 days)
- Adverse Events(56 days)
研究者
相似试验
已完成
2 期
Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated TriglyceridesHypercholesterolemiaHypertriglyceridemiaNCT02585869NeuroBo Pharmaceuticals Inc.161
已完成
3 期
A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)HypercholesterolemiaNCT00092651Organon and Co1,398
已完成
3 期
An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)HypercholesterolemiaNCT00092664Organon and Co1,104
已完成
2 期
Study of Evinacumab (REGN1500) in Participants With Persistent HypercholesterolemiaHypercholesterolemiaNCT03175367Regeneron Pharmaceuticals272
已完成
4 期
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High CholesterolHypercholesterolemiaNCT00145574Daiichi Sankyo194