DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation; Stroke

Treatments: Drug: DU-176b tablets; Drug: Warfarin tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00806624

DU176b-C-J226

Details and patient eligibility

About

This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses. Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary endpoints are incidence of major, clinically relevant non-major and minor bleeding events (all bleeding).

Enrollment: 234 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects 18 to 80 years of age
• Non-valvular AF supported by abnormal ECG documented for two times (interval of more than 1 week) within 6 months prior to randomization.
• CHADS2 Score of at least 1.

Exclusion criteria

• Subjects with mitral valve disease
• Subjects with previous valvular heart surgery
• Contraindication for anticoagulants
• Conditions associated with high risk of bleeding
• Acute coronary syndromes (ACS), percutaneous coronary intervention (PCI), MI, stroke, transient ischemic attack (TIA) or coronary artery/cardiac/other major surgery within the previous 30 days
• Active infective endocarditis or life-expectancy < 12 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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234 participants in 3 patient groups

2

Experimental group

Description:

DU-176b tablets: high-dose

Treatment:

Drug: DU-176b tablets

Drug: DU-176b tablets

3

Active Comparator group

Description:

Warfarin tablets

Treatment:

Drug: Warfarin tablets

1

Experimental group

Description:

DU-176b tablets: low-dose

Treatment:

Drug: DU-176b tablets

Drug: DU-176b tablets