A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Thromboembolism; Atrial Fibrillation

Treatments: Drug: Edoxaban (DU-176b); Drug: warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00504556

DU176b-PRT018

Details and patient eligibility

About

This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.

Enrollment: 1,146 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, 18 to 80 years old.
2. Able to provide written informed consent.
3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)
4. A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2

Exclusion criteria

1. Subjects with mitral valve disease or previous valvular heart surgery
2. Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
3. Known or suspected hereditary or acquired bleeding or coagulation disorder

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,146 participants in 5 patient groups

1

Experimental group

Description:

DU-176b 30mg tablet once daily

Treatment:

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

2

Experimental group

Description:

DU-176b 60mg once daily

Treatment:

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

3

Experimental group

Description:

DU-176b 30mg b.i.d.

Treatment:

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

4

Experimental group

Description:

DU-176b 60mg tablets two times a day

Treatment:

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

Drug: Edoxaban (DU-176b)

5

Active Comparator group

Description:

warfarin tablets

Treatment:

Drug: warfarin