NCT00418366已完成1 期
An Open- Label, 2 Part Study to Investigate the Pharmacokinetics, Safety, and Tolerability of MK0431(Sitagliptin Phosphate) in Patients With Varying Degrees of Renal Insufficiency
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers
研究概览
简要总结
A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Male and non-pregnant females with a clinical diagnosis of renal insufficiency with mild, moderate, severe or end stage renal disease on hemodialysis
- •A body mass index of less than 40 kg per meter squared (body weight in kg divided by height in meters squared)
- •Smokes less than 10 cigarettes/day
排除标准
- •Patients with uncontrolled diabetes or uncontrolled congestive heart failure
- •Patient has abnormal prestudy laboratory measurements including serum potassium or white blood counts
- •Patient has systolic blood pressure below 100 mm Hg or above 180 mm Hg
- •Patient has diastolic blood pressure less than 50 mm Hg systolic or above 100 mmHg
结局指标
主要结局
Determination of the pharmacokinetics of MK0431 (sitagliptin phosphate) in patients with renal insufficiency compared to healthy volunteers
次要结局
- Safety and tolerability in patients with renal insufficiency
研究者
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