Status:
COMPLETED
A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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 fibri...
Eligibility Criteria
Inclusion
- Inclusion criteria Inclusion criteria
- Patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
- 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
- Patients diagnosed as having a valvular heart disease by echocardiography, or patients who had a history of prosthetic valve replacement or valve surgery
- Patients who were to receive electric defibrillation or pharmacological defibrillation during the study period
- Patients who developed stroke or transient ischemic attack within 30 days before the date of informed consent
- 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
- Patients with atrial myxoma or left ventricular thrombosis
- Patients with contraindication to anticoagulant therapies
- Patients scheduled for major surgery or invasive procedure
- Patients having major bleeding from non-gastrointestinal organs within 6 months before the date of informed consent
- Patients with uncontrolled hypertension
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01136408
Start Date
November 1 2005
Last Update
March 19 2014
Active Locations (28)
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1
1160.49.024 Boehringer Ingelheim Investigational Site
Aki-gun, Hiroshima, Japan
2
1160.49.025 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan
3
1160.49.026 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan
4
1160.49.021 Boehringer Ingelheim Investigational Site
Himeji, Hyogo, Japan