A Phase 2 Randomized, Double-Blind, Dose-Response Efficacy and Safety Study of SCH 900271 Compared to Placebo in Subjects With Primary Hypercholesterolemia (Familial and Nonfamilial) or Mixed Hyperlipidemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 619
- 主要终点
- Change From Baseline in Direct LDL-C at Week 8
研究概览
简要总结
The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The safety of SCH 900271 in this participant population will also be evaluated.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides [TG])
- •must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations
- •must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent
排除标准
- •The participant will be excluded from entry if ANY of the criteria listed below are met:
- •use of any investigational drug within 30 days of study entry
- •female of childbearing potential or lactating
- •postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry
- •homozygous familial hypercholesterolemia
- •congestive heart failure New York Heart Association (NYHA) Class III or IV
- •uncontrolled hypertension on or off therapy
- •cardiac arrhythmia requiring medication
- •clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (e.g. clinical CHD, symptomatic carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm)
- •Type 1 Diabetes Mellitus
- •Type 2 Diabetes Mellitus
- •history of mental instability, drug/alcohol abuse or who has been treated or is being treated for severe psychiatric illness, which in the opinion of the investigator, may interfere with optimal participation in the study
- •gastrointestinal ulcer within 3 months of study entry
- •history of coagulopathy
- •history of gout
- •known active or chronic hepatic or biliary disease.
- •known significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease
- •body mass index >40 kg/m^2
- •taking non-steroidal anti-inflammatory drugs (NSAIDS) (acetaminophen and cyclooxygenase-2 [COX-2] inhibitors are allowed)
- •taking more than 100 mg aspirin per day
- •being treated with corticosteroids (oral, intramuscular, or intravascular)
- •more than 3 alcoholic beverages per day or its equivalent (one drink equals 1.5 ounces of 80 proof liquor or equivalent) during study participation
研究组 & 干预措施
SCH 900271 15 mg
Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
干预措施: SCH 900271 15mg (Drug)
SCH 900271 10 mg
Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
干预措施: SCH 900271 (Drug)
SCH 900271 5 mg
Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
干预措施: SCH 900271 (Drug)
SCH 900271 2.5 mg
Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
干预措施: SCH 900271 (Drug)
SCH 900271 1 mg
Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
干预措施: SCH 900271 (Drug)
Placebo
Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Direct LDL-C at Week 8
时间窗: Baseline and Week 8
The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.
次要结局
- Change From Baseline in Direct Non-HDL-C at Week 8(Baseline and Week 8)