NCT00189514已完成2 期
Extension Study of Protocol 137OB-201 to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects.
研究概览
简要总结
This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
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
- •Subject has completed Protocol 137OB-201.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: pramlintide acetate (Drug)
2
Experimental
干预措施: pramlintide acetate (Drug)
3
Experimental
干预措施: pramlintide acetate (Drug)
4
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects.
时间窗: open ended
Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects.
时间窗: open ended
次要结局
- Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters.(open ended)
研究者
研究点 (1)
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