NCT00554216已完成3 期
A Phase III Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in an Adult Population With BMI ≥ 35
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 1,267
- 试验地点
- 2
- 主要终点
- Percent Weight Loss From Baseline to Week 56
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.
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
- Triple (Participant, 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
- •Body mass index (BMI) ≥ 35 kg/m2
- •Informed consent
- •70 years of age or less
- •Triglyceride level ≤ 200 mg/dL with treatment of 0 or 1 medications
- •Blood pressure of ≤ 140/90 mmHg with treatment of 0-2 medications for hypertension
- •Fasting blood glucose level of ≤ 110 mg/dL
排除标准
- •Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
- •Clinically significant renal, hepatic or psychiatric disease
- •Unstable thyroid disease or replacement therapy
- •Nephrolithiasis
- •Obesity of known genetic or endocrine origin
- •Participation in a formal weight loss program or lifestyle intervention
- •History of glaucoma or intraocular pressure
- •Pregnancy or breastfeeding
- •Alcohol abuse
- •Smoking cessation within previous 3 months or plans to quit smoking during study
- •Eating disorders
- •Cholelithiasis within past 6 months
- •Excluded medications
- •Type 2 diabetes
- •Previous bariatric surgery
- •History of bipolar disorder or psychosis
研究组 & 干预措施
VI-0521 Low
Experimental
VI-0521; low dose phentermine/topiramate (PHEN/TPM 3.75 mg/23 mg)
干预措施: VI-0521 (Drug)
VI-0521 Top
Experimental
Top Dose VI-0521 consisting of 15 mg of Phentermine and 92 mg of Topiramate.
干预措施: VI-0521 (Drug)
Placebo
Placebo Comparator
Placebo to match
干预措施: Placebo matched phentermine/topiramate (Drug)
结局指标
主要结局
Percent Weight Loss From Baseline to Week 56
时间窗: baseline to 56 weeks
Percentage of Subjects With at Least 5% Weight Loss at Week 56
时间窗: baseline to 56 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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