Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment
2009年3月24日 更新者:Novartis
An Open-Label, Parallel-Group Study to Determine the Single and Multiple Dose Pharmacokinetics of Vildagliptin and Its Metabolites in Mild, Moderate or Severe Renal Impaired Patients Compared to Age, Sex and Weight-Matched Healthy Volunteers Following Daily Doses of 50 mg Vildagliptin for 14 Days
This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.
研究概览
研究类型
介入性
注册 (预期的)
96
阶段
- 阶段1
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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Kiel、德国
- Novartis Investigator Site
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Florida
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Miami、Florida、美国、33136
- Novartis Investigator Site
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Orlando、Florida、美国、32809
- Novartis Investigator Site
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Minnesota
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Minneapolis、Minnesota、美国、55404
- Novartis Investigator Site
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Tennessee
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Knoxville、Tennessee、美国、37920
- Novartis Investigator Site
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Virginia
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Richmond、Virginia、美国、23298
- Novartis Investigator Site
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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 85年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria (general):
- Men and women (age 18 to 85 years)
- Participants must be nonfertile or using a medically approved birth control method. Additional information regarding this requirement available at screening
- Body mass index (BMI) ≤42 kg/m2 (inclusive)
Inclusion Criteria (for renal insufficient patients):
- Patients with mild, moderate, or severe kidney impairment. Please consult with participating physicians regarding the definitions of these levels of severity.
- Patients with diabetes must be treated with standard anti-diabetic therapy (diet and exercise, stable dose of sulfonylurea, insulin, or metiglinides) and agree to continue for the study duration
Inclusion Criteria (for healthy subjects):
- No current significant medical conditions as determined by history and physical.
- Serum creatinine with a calculated creatinine clearance (CrCl) of >80 ml/min.
- Matched to renal impaired patients in the study by age (±5 years), sex and weight (±10% BMI)
- Vital signs guided by the following ranges:
oral body temperature between 35.0-37.2 °C systolic blood pressure, 100-140 mm Hg diastolic blood pressure, 60-110 mm Hg pulse rate, 45-90 bpm
Exclusion criteria:
- Pregnant or lactating female.
- A history of type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications (eg, ketoacidosis or hyperosmolar state (coma))
- Subjects that have been enrolled in previous vildagliptin studies or other DPP
- 4 inhibitor studies within six months
- History of renal transplant or immunosuppressant therapy
- Acute infections which may affect blood glucose control or other medical condition that may interfere with the interpretation of efficacy and safety data during the study
- Any pre-existing or history of diabetic ulcer
- Any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery or percutaneous coronary intervention, unstable angina or stroke
- Any of the following electrocardiogram (ECG) abnormalities: Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second degree atrioventricular (AV) block (Mobitz 1 and 2), third degree AV block, prolonged QTc (>500 ms)
- Malignancy including leukemia and lymphoma within the last 5 years.
- Liver disease such as cirrhosis or positive hepatitis B and C.
- Any alcohol related hepatic disease.
- Patients undergoing any method of dialysis
- Use of some concomitant medications
- Significant laboratory abnormalities as specified in the protocol
- History of active substance abuse (including alcohol) within the past 2 years.
- Smokers (i.e., 10 or more cigarettes per day)
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
Other protocol-defined inclusion/exclusion criteria may apply
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:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:1
Vildagliptin
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其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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• Pharmacokinetic measures
大体时间:throughout the study
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throughout the study
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次要结果测量
结果测量 |
大体时间 |
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• Safety and tolerability measures
大体时间:throughout the study
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throughout the study
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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。
赞助
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
2007年7月1日
初级完成 (实际的)
2009年1月1日
研究注册日期
首次提交
2007年12月3日
首先提交符合 QC 标准的
2007年12月3日
首次发布 (估计)
2007年12月4日
研究记录更新
最后更新发布 (估计)
2009年3月25日
上次提交的符合 QC 标准的更新
2009年3月24日
最后验证
2009年3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.
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