Safety and Tolerability of Dabigatran Etexilate in Adolescents
2014年6月3日 更新者：Boehringer Ingelheim
Open-label Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given for 3 Days at the End of Standard Anticoagulant Therapy in Children Aged 12 Years to Less Than 18 Years
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
研究概览
研究类型
介入性
注册 (实际的)
9
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
-
-
Alberta
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Edmonton、Alberta、加拿大
- 1160.88.00002 Boehringer Ingelheim Investigational Site
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Ontario
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Ottawa、Ontario、加拿大
- 1160.88.00001 Boehringer Ingelheim Investigational 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
12年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- males or females 12 to less than 18 years of age
- objective diagnosis of primary VTE
- completion of planned treatment course with LMWH or OAC for primary VTE
- written informed consent by parent (legal guardian) and patient assent
Exclusion criteria:
- weight less than 32 kg
- conditions associated with increased risk of bleeding
- severe renal dysfunction or requirement for dialysis
- active infective endocarditis
- hepatic disease
- pregnant females or females not using medically accepted contraceptive method
- anemia or thrombocytopenia
- use of prohibited or restricted drug within previous week
- received investigational drug within past 30 days
- unreliable patients or patients who have any condition that would not allow safe participation in study
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：非随机化
- 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 |
|---|---|
|
实验性的：dabigatran etexilate
open label; patient to receive dabigatran etexilate BID for three days
|
2.14 mg/kg BID to a max 150 mg BID
|
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 |
|---|---|---|
|
Number of Patients With Bleeding Events (Major and Minor)
大体时间：From Screening until 30 days after first drug administration (end of trial visit)
|
Patients were carefully assessed for signs and symptoms of bleeding. Bleeding was to be classified as major or minor. Major bleeding had to satisfy one or more of the following criteria: Overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL in 24 hours, Overt bleeding requiring a transfusion of red blood cells, Overt bleeding which was retroperitoneal, intracranial, intraocular, or intraarticular, any overt bleeding deemed by the attending physician to require discontinuation of study medication. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. |
From Screening until 30 days after first drug administration (end of trial visit)
|
|
Number of Patients With Adverse Events
大体时间：From Screening until 30 days after first drug administration (end of trial visit)
|
Patients with treatment drug related adverse events (DRAEs) and serious adverse events (SAEs) are reported separately for on-treatment and post-treatment period.
Events were considered "on-treatment" if occurring within 72 hours after last drug administration.
|
From Screening until 30 days after first drug administration (end of trial visit)
|
|
Plasma Concentration of Free Dabigatran
大体时间：3 days
|
Plasma concentration of free dabigatran measured at 72 hours after first dose
|
3 days
|
|
Plasma Concentration of Total Dabigatran
大体时间：Day 3
|
Plasma concentration of total dabigatran measured at 72 hours after first dose
|
Day 3
|
|
Thrombin Time (TT) Centrally Measured
大体时间：Day 3
|
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
|
Day 3
|
|
TT Locally Measured
大体时间：Day 3
|
Measurement of TT was performed locally and centrally by Hemoclot Thrombin Inhibitor clotting assay.
|
Day 3
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Activated Partial Thromboplastin Time (aPTT) Centrally Measured
大体时间：Day 3
|
Measurement of aPTT was performed locally and centrally using validated assays.
|
Day 3
|
|
aPTT Locally Measured
大体时间：Day 3
|
Measurement of aPTT was performed locally and centrally using validated assays.
|
Day 3
|
|
Ecarin Clotting Time (ECT)
大体时间：Day 3
|
Measurement of ECT was performed locally and centrally using validated assays.
Descriptive statistics is only performed for the centrally measured ECT.
|
Day 3
|
|
Patients With Clinically Relevant Changes in Any Laboratory Parameter, Electrocardiogram (ECG) or Vital Signs
大体时间：Baseline and 3 days
|
Changes in any laboratory parameter, ECG or vital signs were judged clinically relevant by the investigator.
|
Baseline and 3 days
|
|
Occurences of Clinical Outcome
大体时间：3 days
|
Occurrences of clinical outcomes including recurrent venous thrombolic event (VTE), post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and VTE related mortality objectively assessed for example by ultrasound, venography or computed chromatography (CT) scan (based on the thrombus location).
Number of patients with particular clinical outcome are reported.
|
3 days
|
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
2009年6月1日
初级完成 (实际的)
2012年2月1日
研究注册日期
首次提交
2009年2月13日
首先提交符合 QC 标准的
2009年2月13日
首次发布 (估计)
2009年2月16日
研究记录更新
最后更新发布 (估计)
2014年6月9日
上次提交的符合 QC 标准的更新
2014年6月3日
最后验证
2013年12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.