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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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01136408
First received: May 19, 2010
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
 Drug: Dabigatran etexilate
Drug: Warfarin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Frequency (Occurrence Rates) of Major Bleeding Event [ Time Frame: Treatment period: from the first dose of study medication and ending 6 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
    The percentage of patients with major bleeding event

  • Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event [ Time Frame: Treatment period: from the first dose of study medication and ending 6 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
    The percentage of patients with clinically relevant bleeding event

  • Frequency (Occurrence Rates) of Nuisance Bleeding Event [ Time Frame: Treatment period: from the first dose of study medication and ending 6 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
    The percentage of patients with nuisance bleeding event


Secondary Outcome Measures:
  • Frequency (Occurrence Rates) of a Composite Clinical Endpoint. [ Time Frame: Treatment period: from the first dose of study medication and ending 6 days after the last dose of study medication ] [ Designated as safety issue: No ]
    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)

  • Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal) [ Time Frame: Treatment period: from the first dose of study medication and ending 6 days after the last dose of study medication ] [ Designated as safety issue: No ]
    The percentage of patients with ischemic or haemorrhagic stroke (fatal or non-fatal)

  • Frequency (Occurrence Rates) of Transient Ischemic Attack [ Time Frame: Treatment period: from the first dose of study medication and ending 6 days after the last dose of study medication ] [ Designated as safety issue: No ]
    The percentage of patients with transient ischemic attack

  • Frequency (Occurrence Rates) of Systemic Embolism [ Time Frame: Treatment period: from the first dose of study medication and ending 6 days after the last dose of study medication ] [ Designated as safety issue: No ]
    The percentage of patients with systemic embolism

  • Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal) [ Time Frame: Treatment period: from the first dose of study medication and ending 6 days after the last dose of study medication ] [ Designated as safety issue: No ]
    The percentage of patients with myocardial infarction (fatal or non-fatal)

  • Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events [ Time Frame: Treatment period: from the first dose of study medication and ending 6 days after the last dose of study medication ] [ Designated as safety issue: No ]
    The percentage of patients with other major adverse cardiac events

  • Frequency (Occurrence Rates) of Death [ Time Frame: Treatment period: from the first dose of study medication and ending 6 days after the last dose of study medication ] [ Designated as safety issue: No ]
    The percentage of patients with death


Enrollment: 174
Study Start Date: November 2005
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran etexilate 220 mg daily
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
 Drug: Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Experimental: Dabigatran etexilate 300 mg daily
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
 Drug: Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Active Comparator: Warfarin
Dose-adjusted warfarin based on target INR values
 Drug: Warfarin
Dose-adjusted warfarin based on target INR values

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136408

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01136408     History of Changes
Other Study ID Numbers: 1160.49
Study First Received: May 19, 2010
Results First Received: November 18, 2010
Last Updated: May 23, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013