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

Daiichi Sankyo Co., Ltd.234 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

234

Conditions

Atrial Fibrillation Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Hong Kong, China

Unnamed facility

Singapore, Singapore

Unnamed facility

Seoul, South Korea

Unnamed facility

Taipei, Taiwan

Outcomes

Primary Outcomes

Incidence of All Bleeding

Incidence of all bleeding (major, clinically relevant non-major and minor) in two fixed dosage of DU-176b in comparison with warfarin as active control in subjects with non-valvular AF.

Time frame: 6 months

Secondary Outcomes

Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition

Time frame: 6 months

Evaluation of Effects on Biomarkers of Thrombus Formation

Time frame: 6 months

Evaluation of Plasma Concentration of DU-176

Time frame: 6 months

Evaluation of Effects on Pharmacodynamic Biomarkers

Time frame: 6 months

Evaluation of All Clinical and Laboratory Safety Data.

Time frame: 6 months