NCT02591836已完成2 期
An 8-Week, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of Gemcabene Administered as Monotherapy or in Combination With Atorvastatin in the Treatment of Hypercholesterolemic Patients
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
- 277
- 主要终点
- LDL-C percent change from baseline
研究概览
简要总结
The primary purpose of this placebo-controlled study is to evaluate the low-density lipoprotein cholesterol (LDL-C) efficacy and dose-response of gemcabene 300, 600 and 900 mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day to hypercholesterolemic patients.
Secondary purposes include evaluating the effects of high-sensitivity C-reactive protein (hsCRP), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) and apolipoprotein B (ApoB), and safety and efficacy of gemcabene monotherapy and gemcabene/atorvastatin combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females
- •18-70 years old
- •Received a statin as monotherapy while having a LDL-C >100 mg d/L at initial clinical washout visit OR
- •Received no lipid-altering drugs since the initial clinic washout visit and had a mean LDL-C as follows at 2 qualifying visits:
- •≥ 130 mg/dL if National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) Coronary Heard Disease (CHD) risk ≥ 10%; OR
- •≥ 160 mg/dL if NCEP ATP III CHD risk < 10%
- •Had variability of 2 qualifying LDL-C <20% (i.e. lowest value/highest value >0.8). An additional qualifying visit may have been completed by patients who were washing off lipid medication in order to reassess LDL-C variability; and
- •Had a mean LDL-C < 250 mg/dL at 2 qualifying visits
排除标准
- •Women of childbearing potential, pregnant or lactating;
- •Body Mass Index (BMI) >38kg/m²;
- •TG >400 mg/dL at Visit B2 or B3
- •Unexplained creatinine phosphokinase (CPK) > 3 x Upper Limit of Normal (ULN) or those with a history of unexplained myopathy (including rhabdomyolysis);
- •Documented cardiac history of: Myocardial infarction*, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, symptomatic carotid artery disease or peripheral artery disease, ventricular arrhythmias, recurrent supraventricular tachycardia, abnormal QTC interval (QT corrected > 0.44 sec), heart failure or any other major cardiovascular event resulting in hospitalization
- •Uncontrolled hypertension*
- •Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c >8%) or any diabetic patient who takes insulin and/or thiazolidinediones
- •Renal dysfunction including chronic renal failure or insufficiency, or creatinine >2.0 mg/dL;
- •Hepatic dysfunction
- •Uncontrolled hypothyroidism
- •Abnormal urinalysis
- •Currently taking any of the following medications:
- •Potent CYP3A4 inhibitors including indinavir, nelfinavir, ritonavir, saquinavir, amiodarone, cimetidine, clarithromycin, erythromycin, erythromycin, fluoxetine, itraconazole, ketoconazole, nefazodone and troleandomycin as well as grapefruit juice;
- •Thiazolidinediones (Avandia, Actos);
- •Immunosuppressive agents;
- •St. John's wort
- •Taking any of the following lipid-altering medications within 5 weeks prior to randomization:
- •Lipid-regulating drugs: Niacin (crystalline >500mg/day, slow release or time release), psyllium preparation such as Metamucil (>2 tablespoons/day), fibrates and derivatives, bile cholesterol absorption inhibitors including ezetimibe;
- •Any supplement containing plan sterols/stanols (i.e. Benecol, beta-sitosterol, Cholestatin, Phytoquest, Take Control) or cholestin (i.e. Chinese red yeast, fermented on rice; Hong Qu, Hong Chu, Herbvalin, Ruby Monascus, Monascus purpureus rice);
- •Neomycin (oral);
- •Adrenocortical steroids*
- •Sibutramine (Meridia);
- •Orlistat (Xenical);
- •Isotretinoin
研究组 & 干预措施
Gemcabene 300 mg
Experimental
Gemcabene 300 mg QD
干预措施: Gemcabene (Drug)
Gemcabene 600 mg
Experimental
Gemcabene 600 mg QD
干预措施: Gemcabene (Drug)
Gemcabene 900 mg
Experimental
Gemcabene 900 mg QD
干预措施: Gemcabene (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Atorvastatin 10 mg
Active Comparator
干预措施: Atorvastatin (Drug)
Atorvastatin 40 mg
Active Comparator
干预措施: Atorvastatin (Drug)
Atorvastatin 80 mg
Active Comparator
干预措施: Atorvastatin (Drug)
Gemcabene 300 mg & Atorvastatin 10 mg
Experimental
干预措施: Gemcabene (Drug)
Gemcabene 300 mg & Atorvastatin 10 mg
Experimental
干预措施: Atorvastatin (Drug)
Gemcabene 300 mg & Atorvastatin 40 mg
Experimental
干预措施: Gemcabene (Drug)
Gemcabene 300 mg & Atorvastatin 40 mg
Experimental
干预措施: Atorvastatin (Drug)
Gemcabene 300 mg & Atorvastatin 80 mg
Experimental
干预措施: Gemcabene (Drug)
Gemcabene 300 mg & Atorvastatin 80 mg
Experimental
干预措施: Atorvastatin (Drug)
Gemcabene 600 mg & Atorvastatin 10 mg
Experimental
干预措施: Gemcabene (Drug)
Gemcabene 600 mg & Atorvastatin 10 mg
Experimental
干预措施: Atorvastatin (Drug)
Gemcabene 600 mg & Atorvastatin 40 mg
Experimental
干预措施: Gemcabene (Drug)
Gemcabene 600 mg & Atorvastatin 40 mg
Experimental
干预措施: Atorvastatin (Drug)
Gemcabene 600 mg & Atorvastatin 80 mg
Experimental
干预措施: Gemcabene (Drug)
Gemcabene 600 mg & Atorvastatin 80 mg
Experimental
干预措施: Atorvastatin (Drug)
Gemcabene 900 mg & Atorvastatin 10 mg
Experimental
干预措施: Gemcabene (Drug)
Gemcabene 900 mg & Atorvastatin 10 mg
Experimental
干预措施: Atorvastatin (Drug)
Gemcabene 900 mg & Atorvastatin 40 mg
Experimental
干预措施: Gemcabene (Drug)
Gemcabene 900 mg & Atorvastatin 40 mg
Experimental
干预措施: Atorvastatin (Drug)
Gemcabene 900 mg & Atorvastatin 80 mg
Experimental
干预措施: Gemcabene (Drug)
Gemcabene 900 mg & Atorvastatin 80 mg
Experimental
干预措施: Atorvastatin (Drug)
结局指标
主要结局
LDL-C percent change from baseline
时间窗: 56 days
次要结局
- Apolipoprotein-B percent change from baseline(56 days)
- Adverse Events(56 days)
- Clinical Laboratory(56 days)
- HDL-C percent change from baseline(56 days)
- TG percent change from baseline(56 days)
研究者
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