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A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin

2014年2月18日 更新者：Boehringer Ingelheim

Open Label, Randomised Exploratory Dose Response Study in Pharmacodynamics and Safety of BIBR 1048 (110 mg Twice Daily (b.i.d.) and 150 mg b.i.d.) for 12 Weeks in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin

The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with warfarin.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

174

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

  • 日本
      • Aki-gun, Hiroshima、日本
        • 1160.49.024 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka、日本
        • 1160.49.025 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka、日本
        • 1160.49.026 Boehringer Ingelheim Investigational Site
      • Himeji, Hyogo、日本
        • 1160.49.021 Boehringer Ingelheim Investigational Site
      • Iizuka,Fukuoka、日本
        • 1160.49.027 Boehringer Ingelheim Investigational Site
      • Kyoto, Kyoto、日本
        • 1160.49.013 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi、日本
        • 1160.49.011 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi、日本
        • 1160.49.012 Boehringer Ingelheim Investigational Site
      • Naka-gun, Ibaragi、日本
        • 1160.49.004 Boehringer Ingelheim Investigational Site
      • Okayama, Okayama、日本
        • 1160.49.022 Boehringer Ingelheim Investigational Site
      • Okayama, Okayama、日本
        • 1160.49.023 Boehringer Ingelheim Investigational Site
      • Oota, Tokyo、日本
        • 1160.49.006 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka、日本
        • 1160.49.016 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka、日本
        • 1160.49.017 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka、日本
        • 1160.49.018 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka、日本
        • 1160.49.019 Boehringer Ingelheim Investigational Site
      • Sakai, Osaka、日本
        • 1160.49.020 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido、日本
        • 1160.49.001 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido、日本
        • 1160.49.028 Boehringer Ingelheim Investigational Site
      • Sendai, Miyagi、日本
        • 1160.49.002 Boehringer Ingelheim Investigational Site
      • Shinjuku, Tokyo、日本
        • 1160.49.005 Boehringer Ingelheim Investigational Site
      • Suita, Osaka、日本
        • 1160.49.014 Boehringer Ingelheim Investigational Site
      • Suita, Osaka、日本
        • 1160.49.015 Boehringer Ingelheim Investigational Site
      • Tokorozawa, Saitama、日本
        • 1160.49.007 Boehringer Ingelheim Investigational Site
      • Toyama, Toyama、日本
        • 1160.49.009 Boehringer Ingelheim Investigational Site
      • Tsuchiura, Ibaragi、日本
        • 1160.49.003 Boehringer Ingelheim Investigational Site
      • Ueda, Nagano、日本
        • 1160.49.029 Nagano National Hospital
      • Yokohama, Kanagawa、日本
        • 1160.49.008 Boehringer Ingelheim Investigational Site

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

20年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria Inclusion criteria

  1. Patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent)

  2. Patients who had additional risk factor for thromboembolism; one or more of the following conditions/events:

    • Hypertension
    • Diabetes mellitus
    • Left-side heart failure
    • A previous ischemic stroke or transient ischemic attack
    • Age 75 years or older
    • A history of coronary artery diseases

Exclusion criteria Exclusion criteria

  1. Patients diagnosed as having a valvular heart disease by echocardiography, or patients who had a history of prosthetic valve replacement or valve surgery
  2. Patients who were to receive electric defibrillation or pharmacological defibrillation during the study period
  3. Patients who developed stroke or transient ischemic attack within 30 days before the date of informed consent
  4. Patients who developed myocardial infarction or were admitted to hospital due to acute coronary syndrome or for percutaneous transluminal coronary angioplasty within 3 months before the date of informed consent or patients underwent coronary stenting within 6 months before the date of informed consent
  5. Patients with atrial myxoma or left ventricular thrombosis
  6. Patients with contraindication to anticoagulant therapies
  7. Patients scheduled for major surgery or invasive procedure
  8. Patients having major bleeding from non-gastrointestinal organs within 6 months before the date of informed consent
  9. Patients with uncontrolled hypertension

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：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 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 220 mg daily
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
药品：Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
药品：Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
实验性的：Dabigatran etexilate 300 mg daily
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
药品：Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
药品：Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
有源比较器：Warfarin
Dose-adjusted warfarin based on target INR values
药品：华法林
根据目标 INR 值调整剂量的华法林

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
Frequency (Occurrence Rates) of Major Bleeding Event
大体时间：upto 15 weeks

The percentage of patients with major bleeding event.

Major bleeding was defined as any bleed fulfilling one of the following conditions:

  • Fatal or life-threatening
  • Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing)
  • Bleeding requiring surgical treatment
  • Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more
  • Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL
upto 15 weeks
Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event
大体时间：upto 15 weeks

The percentage of patients with clinically relevant bleeding event.

Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event:

  • A skin haematoma of at least 25 sqcm
  • Spontaneous nose bleed lasting for more than 5 minutes
  • Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)
  • Spontaneous rectal bleeding (more than spotting on toilet paper)
  • Gingival bleeding lasting for more than 5 minutes
  • Bleeding leading to hospitalisation
  • Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)
  • Any other bleeding considered clinically relevant by the investigator
upto 15 weeks
Frequency (Occurrence Rates) of Nuisance Bleeding Event
大体时间：Upto 15 weeks

The percentage of patients with nuisance bleeding event

Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event:

  • A skin haematoma of at least 25 sqcm
  • Spontaneous nose bleed lasting for more than 5 minutes
  • Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)
  • Spontaneous rectal bleeding (more than spotting on toilet paper)
  • Gingival bleeding lasting for more than 5 minutes
  • Bleeding leading to hospitalisation
  • Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)
  • Any other bleeding considered clinically relevant by the investigator
Upto 15 weeks
Incidence and Severity of Adverse Events
大体时间：Upto 15 weeks
Intensity of event is categorised as mild, moderate and severe.
Upto 15 weeks
Discontinuation of the Study Drug Due to Adverse Events
大体时间：Upto 15 weeks
Discontinuation of the study drug due to adverse events.
Upto 15 weeks
Changes in Laboratory Test Values
大体时间：12 weeks
The number of patients with ALT, AST, alkaline phosphatase, or bilirubin exceeded the upper limit of normal (ULN) range
12 weeks

次要结果测量

结果测量
措施说明
大体时间
Frequency (Occurrence Rates) of a Composite Clinical Endpoint.
大体时间：Upto 15 weeks
Percentage of patients with the composite clinical endpoint (ischemic or haemorrhagic stroke (fatal or non-fatal), transient ischemic attacks, systemic embolism, myocardial infarction (fatal or non-fatal), other major adverse cardiac events, and death)
Upto 15 weeks
Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal)
大体时间：Upto 15 weeks
The percentage of patients with ischemic or haemorrhagic stroke (fatal or non-fatal)
Upto 15 weeks
Frequency (Occurrence Rates) of Transient Ischemic Attack
大体时间：Upto 15 weeks
The percentage of patients with transient ischemic attack
Upto 15 weeks
Frequency (Occurrence Rates) of Systemic Embolism
大体时间：Upto 15 weeks
The percentage of patients with systemic embolism
Upto 15 weeks
Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal)
大体时间：Upto 15 weeks
The percentage of patients with myocardial infarction (fatal or non-fatal)
Upto 15 weeks
Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events
大体时间：Upto 15 weeks
The percentage of patients with other major adverse cardiac events
Upto 15 weeks
Frequency (Occurrence Rates) of Death
大体时间：Upto 15 weeks
The percentage of patients with death
Upto 15 weeks
Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time)
大体时间：Week 0,1,4 and 12
The blood coagulation parameter aPTT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.
Week 0,1,4 and 12
Anticoagulation Effects Trough ECT (Ecarin Clotting Time)
大体时间：Week 0,1,4 and 12
The blood coagulation parameter ECT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.
Week 0,1,4 and 12
Anticoagulation Effects Trough INR (International Normalised Ratio)
大体时间：Week 0,1,4 and 12
The blood coagulation parameter INR was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.
Week 0,1,4 and 12
Anticoagulation Effects Trough 11-dehydrothromboxane B2
大体时间：Week 0 and 12
Analysis based on concomitant use of aspirin compared to no aspirin users. 11-dehydrothromboxane B2 is measured in urine of patients.
Week 0 and 12
Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration
大体时间：Week 1,4 and 12
Week 1,4 and 12

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

Boehringer Ingelheim

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

2005年11月1日

初级完成 (实际的)

2006年9月1日

研究注册日期

首次提交

2010年5月19日

首先提交符合 QC 标准的

2010年6月2日

首次发布 (估计)

2010年6月3日

研究记录更新

最后更新发布 (估计)

2014年3月19日

上次提交的符合 QC 标准的更新

2014年2月18日

最后验证

2014年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1160.49

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.

Dabigatran etexilate的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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