NCT02585869已完成2 期
A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI-1027 in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
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
- 161
- 主要终点
- HDL-C - percent change from baseline
研究概览
简要总结
The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or naturally postmenopausal or surgically menopausal women
- •18 to 80 years of age
- •Baseline HDL-C <35 mg/dL (0.9 mmol/L)
排除标准
- •Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
- •Body Mass Index (BMI) >35 kg/m2
- •Uncontrolled Hypertension >95 mm Hg
- •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)
- •Uncontrolled hypothyroidism (TSH >1.5 × 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 3 months
研究组 & 干预措施
Gemcabene 150 mg
Experimental
Gemcabene 150 mg once daily (QD)
干预措施: Gemcabene 150 mg (Drug)
Gemcabene 300 mg
Experimental
Gemcabene 300 mg once daily (QD)
干预措施: Gemcabene 300 mg (Drug)
Gemcabene 600 mg
Experimental
Gemcabene 600 mg once daily (QD)
干预措施: Gemcabene 600 mg (Drug)
Gemcabene 900 mg
Experimental
Gemcabene 900 mg once daily (QD)
干预措施: Gemcabene 900 mg (Drug)
Placebo
Placebo Comparator
Placebo once daily (QD)
干预措施: Placebo (Drug)
结局指标
主要结局
HDL-C - percent change from baseline
时间窗: 84 days
次要结局
- Adverse Events(84 days)
- Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline(84 days)
- Clinical Laboratory - hematology, chemistry, urinalysis(84 days)
研究者
相似试验
已完成
2 期
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin TherapyHypercholesterolemiaNCT02571257NeuroBo Pharmaceuticals Inc.66
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
Safety Study of BMS-823778 in Subjects With HypercholesterolemiaDyslipidemiaNCT01112423Bristol-Myers Squibb60
已完成
2 期
Safety Study of BMS-770767 in Subjects With HypercholesterolemiaDyslipidemiaNCT01058083Bristol-Myers Squibb81