Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
2016年8月10日 更新者：Janssen Research & Development, LLC
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Efficacy of the Co-administration of Canagliflozin 300 mg and Phentermine 15 mg Compared With Placebo for the Treatment of Non-diabetic Overweight and Obese Subjects
The purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.
研究概览
地位
完全的
条件
详细说明
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants.
The study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo.
All participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).
研究类型
介入性
注册 (实际的)
335
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Arizona
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Phoenix、Arizona、美国
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California
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Walnut Creek、California、美国
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Florida
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Jacksonville、Florida、美国
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Idaho
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Meridian、Idaho、美国
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Indiana
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Evansville、Indiana、美国
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Kentucky
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Lexington、Kentucky、美国
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Louisville、Kentucky、美国
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Louisiana
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New Orleans、Louisiana、美国
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Massachusetts
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Milford、Massachusetts、美国
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New York
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Manlius、New York、美国
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Rhode Island
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Warwick、Rhode Island、美国
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South Carolina
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Mt Pleasant、South Carolina、美国
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Tennessee
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Nashville、Tennessee、美国
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Texas
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Dallas、Texas、美国
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Odessa、Texas、美国
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Virginia
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Norfolk、Virginia、美国
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Wisconsin
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Wauwatosa、Wisconsin、美国
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Must have BMI >=30 kg/m2 and <50 kg/m2 at screening or BMI >=27 kg/m2 and <50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia
- Must have stable weight, ie, change of < =5% in the 3 months before screening
- Must agree to utilize a highly effective method of birth control
Exclusion Criteria:
- An established diagnosis of diabetes mellitus
- Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)
- Has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria
- Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
- Has an Glycated hemoglobin (HBA1c) greater than or equal (>=) to 65 percent
- An average of 3 seated blood pressure (BP) readings of systolic BP >= 160 mm Hg and/or Diastolic BP >= 100 millimeters of mercury at screening
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Canagliflozin + Phentermine
300 mg capsule of Canagliflozin along with 15 mg capsule of Phentermine, taken once daily, orally for 26 weeks.
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300 mg capsule, taken once daily, orally for 26 weeks.
其他名称：
15 mg capsule, taken once daily, orally for 26 weeks.
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实验性的：Canagliflozin + Placebo (Phentermine)
300 mg capsule of Canagliflozin along with matching placebo to Phentermine, taken once daily, orally for 26 weeks.
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300 mg capsule, taken once daily, orally for 26 weeks.
其他名称：
Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
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实验性的：Phentermine + Placebo (Canagliflozin)
15 mg capsule of Phentermine along with matching placebo to Canagliflozin, taken once daily, orally for 26 weeks.
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15 mg capsule, taken once daily, orally for 26 weeks.
Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
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安慰剂比较：Placebo
Matching placebo to Canagliflozin and Phentermine, taken once daily, orally for 26 weeks.
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Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percent Change From Baseline in Body Weight at Week 26
大体时间：Week 26
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The percent change from baseline in body weight at Week 26 was analysed.
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Week 26
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26
大体时间：Week 26
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Percentage of participants with weight loss >= 5 percent were analysed at week 26.
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Week 26
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Change From Baseline in Systolic Blood Pressure at Week 26
大体时间：Week 26
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Change from baseline in systolic blood pressure was analysed at week 26.
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Week 26
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Absolute Change From Baseline in Body Weight at Week 26
大体时间：Week 26
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Absolute change from baseline in body weight was analysed at week 26.
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Week 26
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26
大体时间：Week 26
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Change from baseline in diastolic blood pressure (DBP) at week 26.
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Week 26
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Change From Baseline in Pulse Rate at Week 26
大体时间：Week 26
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Change from baseline in pulse rate at week 26
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Week 26
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Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26
大体时间：Week 26
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Percentage of participants with weight loss >= 10 percent at week 26.
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Week 26
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年9月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2014年9月16日
首先提交符合 QC 标准的
2014年9月16日
首次发布 (估计)
2014年9月17日
研究记录更新
最后更新发布 (估计)
2016年10月6日
上次提交的符合 QC 标准的更新
2016年8月10日
最后验证
2016年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.