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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Warfarin; Drug: Dabigatran etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01136408

1160.49

Details and patient eligibility

About

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.

Enrollment: 174 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 3 patient groups

Dabigatran etexilate 220 mg daily

Experimental group

Description:

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

Treatment:

Drug: Dabigatran etexilate

Drug: Dabigatran etexilate

Dabigatran etexilate 300 mg daily

Experimental group

Description:

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

Treatment:

Drug: Dabigatran etexilate

Drug: Dabigatran etexilate

Warfarin

Active Comparator group

Description:

Dose-adjusted warfarin based on target INR values

Treatment:

Drug: Warfarin