Assessment of Electrophysiological Effects of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects.
2014年6月20日 更新者:Boehringer Ingelheim
Assessment of Electrophysiological Effects of 150 mg and 600 mg of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind Three-way Crossover Study With an Open Label Positive Control (Moxifloxacin)
To investigate if dabigatran has a clinically relevant impact on the cardiac electrophysiology that is manifest as prolongation in QT-interval.
研究概览
研究类型
介入性
注册 (实际的)
40
阶段
- 阶段1
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
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy female (at least 1/3) and male (at least 1/3) volunteers as determined by the results of screening according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
- Age >= 18 and Age <= 65 years
- BMI >= 20.0 and BMI <=29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including BP, pulse rate (PR) and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- History of any bleeding disorder or acute blood coagulation defect
- Hypersensitivity to moxifloxacin and/or related drugs of this class
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- History of additional risk factors for Torsade des Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome)
Any screening ECG value outside of the reference range of clinical relevance including, but not limited to heart rate of >80 bpm or <45 bpm, PR interval >220 ms, QRS interval >120 ms, QT interval >470 ms or QTcB or QTcF >450 ms
For female subjects:
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilisation, intrauterine device (IUD)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
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:交叉作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:莫西沙星
|
|
实验性的:达比加群酯低
|
|
实验性的:达比加群酯高
|
|
安慰剂比较:Placebo to dabigatran etexilate
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Change from baseline in mean time-matched QTc Interval
大体时间:at 1.5, 2, and 3 hours following administration
|
at 1.5, 2, and 3 hours following administration
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Mean of the QTcI values of all ECGs
大体时间:from 1 to 6 hours following administration
|
from 1 to 6 hours following administration
|
Change from baseline of the QTcI
大体时间:from 1 to 24 hours following administration
|
from 1 to 24 hours following administration
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
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
2006年3月1日
初级完成 (实际的)
2006年5月1日
研究注册日期
首次提交
2014年6月20日
首先提交符合 QC 标准的
2014年6月20日
首次发布 (估计)
2014年6月23日
研究记录更新
最后更新发布 (估计)
2014年6月23日
上次提交的符合 QC 标准的更新
2014年6月20日
最后验证
2014年6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.
安慰剂的临床试验
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的