NCT00388609终止2 期
A Randomized, Double-blind, Placebo-Controlled, Parallel Arm, Multiple-Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BMS-646256 in Obese and High Risk Overweight Subjects
Bristol-Myers Squibb10 个研究点 分布在 1 个国家目标入组 705 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 705
- 试验地点
- 10
- 主要终点
- Percent change in body weight from the start of the study
研究概览
简要总结
The purpose of this study is to learn if BMS-646256 can cause weight loss in men and women who are:
- overweight with high blood pressure or high cholesterol or
- obese
The safety of this treatment will also be studied
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, ages ≥18 to ≤70 years old with a Body Mass Index (BMI) ≥30 to ≤45 kg/m² OR BMI >27 to <30 kg/m² with hypertension and/or dyslipidemia defined as:
- •Hypertension defined as treatment with an antihypertensive agent or mean systolic blood pressure ≥140 and ≤160 mmHg and/or diastolic blood pressure ≥ 90 and ≤ 105 mmHg
- •Dyslipidemia defined as stable dose treatment with a statin, fibrate or ezetimibe for ≥ 6 weeks and/or triglycerides ≥ 150 and ≤ 600 mg/dL, LDL ≥ 130 and ≤ 300 mg/dL, or HDL < 40 mg/dL
排除标准
- •Type 1 or 2 diabetes mellitus
- •history of MI in the prior 6 months
- •history of heart failure
- •history of symptomatic arrhythmia
- •active hepatic disease
- •any documented muscle disease
- •history of neurological symptoms or disease (including but not limited to tremor, ataxia, dizziness, neuropathy, or episodes of confusion, history of seizures, stroke or TIA)
- •known history of major psychiatric conditions (e.g. schizophrenia anxiety disorder, dementia or bipolar disorder as defined by DSM IV criteria)
- •history of depression or suicide attempt or ideation
- •previous history of surgical procedures for weight loss (e.g., stomach stapling, bypass)
- •uncontrolled blood pressure
研究组 & 干预措施
T
Experimental
5 mg (ST) to 50 mg (LT)
干预措施: BMS-646256 (Drug)
U
Experimental
10 mg (ST) to 50 mg (LT)
干预措施: BMS-646256 (Drug)
V
Experimental
25 mg (ST) to 50 mg (LT)
干预措施: BMS-646256 (Drug)
W
Experimental
50 mg (ST and LT)
干预措施: BMS-646256 (Drug)
X
Experimental
25 mg/d (X1 wk), 5 mg/d (X11 wks) (ST) to 50 mg (LT)
干预措施: BMS-646256 (Drug)
Z
Experimental
Open label: 50 mg/d (X 4 wks) 100 mg/wk (X8 wks) (ST) to 50 mg (LT)
Once daily (x 4 weeks), once daily (x 8 weeks)
干预措施: BMS-646256 (Drug)
Y
Placebo Comparator
0 mg (ST and LT)
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in body weight from the start of the study
时间窗: Average of Week 11 and 12
次要结局
- BMI(Change from baseline to Week 12, Week 32, and Week 44)
- waist circumference(Change from baseline to Week 12, Week 32, and Week 44)
- hormonal measures of insulin sensitivity and safety(Percent change from baseline to Week 12, Week 32, and Week 44)
- Change in body weight(Average of Week 11 and 12)
- blood pressure(Change from baseline to Week 12, Week 32, and Week 44)
- blood lipids(Change from baseline to Week 12, Week 32, and Week 44)
- incidence of adverse events and lab abnormalities(throughout the study)
- Change and percent change in body weight(at Week 32 from baseline and Week 12)
- Time-matched change from baseline in QTc(at Week 12 and Week 32)
研究者
研究点 (10)
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