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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

NCT ID: NCT01136408

Last Updated: 2014-03-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dabigatran etexilate 220 mg daily

Dabigatran etexilate 110 mg capsule, twice a day, oral administration

Group Type EXPERIMENTAL

Dabigatran etexilate

Intervention Type DRUG

Dabigatran etexilate 110 mg capsule, twice a day, oral administration

Dabigatran etexilate 300 mg daily

Dabigatran etexilate 150 mg capsule, twice a day, oral administration

Group Type EXPERIMENTAL

Dabigatran etexilate

Intervention Type DRUG

Dabigatran etexilate 150 mg capsule, twice a day, oral administration

Warfarin

Dose-adjusted warfarin based on target INR values

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Dose-adjusted warfarin based on target INR values

Interventions

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Dabigatran etexilate

Dabigatran etexilate 110 mg capsule, twice a day, oral administration

Intervention Type DRUG

Dabigatran etexilate

Dabigatran etexilate 150 mg capsule, twice a day, oral administration

Intervention Type DRUG

Warfarin

Dose-adjusted warfarin based on target INR values

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.49.024 Boehringer Ingelheim Investigational Site

Aki-gun, Hiroshima, , Japan

Site Status

1160.49.025 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

Site Status

1160.49.026 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

Site Status

1160.49.021 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, , Japan

Site Status

1160.49.027 Boehringer Ingelheim Investigational Site

Iizuka,Fukuoka, , Japan

Site Status

1160.49.013 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

Site Status

1160.49.011 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1160.49.012 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1160.49.004 Boehringer Ingelheim Investigational Site

Naka-gun, Ibaragi, , Japan

Site Status

1160.49.022 Boehringer Ingelheim Investigational Site

Okayama, Okayama, , Japan

Site Status

1160.49.023 Boehringer Ingelheim Investigational Site

Okayama, Okayama, , Japan

Site Status

1160.49.006 Boehringer Ingelheim Investigational Site

Oota, Tokyo, , Japan

Site Status

1160.49.016 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1160.49.017 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1160.49.018 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1160.49.019 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1160.49.020 Boehringer Ingelheim Investigational Site

Sakai, Osaka, , Japan

Site Status

1160.49.001 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1160.49.028 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1160.49.002 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, , Japan

Site Status

1160.49.005 Boehringer Ingelheim Investigational Site

Shinjuku, Tokyo, , Japan

Site Status

1160.49.014 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

1160.49.015 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

1160.49.007 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, , Japan

Site Status

1160.49.009 Boehringer Ingelheim Investigational Site

Toyama, Toyama, , Japan

Site Status

1160.49.003 Boehringer Ingelheim Investigational Site

Tsuchiura, Ibaragi, , Japan

Site Status

1160.49.029 Nagano National Hospital

Ueda, Nagano, , Japan

Site Status

1160.49.008 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1160.49

Identifier Type: -

Identifier Source: org_study_id

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