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

Phase 2

Completed

• Conditions: Atrial Fibrillation; Stroke
• Interventions: Drug: Warfarin tablets; Drug: DU-176b tablets

• Registration Number: NCT00806624
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-10
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Study Completion: 2009-11
• Status Verified: 2015-01
• Results First Submitted: 2015-01-15
• Results First Submitted QC: 2015-01-15
• Results First Posted: 2015-01-26
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Warfarin tablets	Warfarin tablets
1	DU-176b tablets	DU-176b tablets: low-dose
2	DU-176b tablets	DU-176b tablets: high-dose

Primary Outcome Measures

Name	Time	Method
Incidence of All Bleeding	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Incidence of Major Adverse Cardiovascular Events: Stroke, Systemic Embolic Event, Myocardial Infarction, Cardiovascular Death, and Hospitalization for Any Cardiac Condition	6 months
Evaluation of Effects on Biomarkers of Thrombus Formation	6 months
Evaluation of Effects on Pharmacodynamic Biomarkers	6 months
Evaluation of All Clinical and Laboratory Safety Data.	6 months
Evaluation of Plasma Concentration of DU-176	6 months