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

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ) Identifier:
First received: December 10, 2008
Last updated: January 15, 2015
Last verified: January 2015
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).

Condition Intervention Phase
Atrial Fibrillation Stroke Drug: DU-176b tablets Drug: Warfarin tablets Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Parallel Group, Multi-Center, Multi-National Study for the Evaluation of Safety and Efficacy of Two Fixed Dosages of DU-176b in Subjects With Non-Valvular Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):

Primary Outcome Measures:
  • Incidence of All Bleeding [ Time Frame: 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:
  • 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 ]

Enrollment: 234
Study Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
DU-176b tablets: high-dose
Drug: DU-176b tablets
DU-176b tablets taken once daily for up to 3 months
Active Comparator: 3
Warfarin tablets
Drug: Warfarin tablets
Warfarin tablets taken once daily for up to 3 months
Experimental: 1
DU-176b tablets: low-dose
Drug: DU-176b tablets
DU-176b tablets taken once daily for up to 3 months


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00806624

Hong-Kong, China
Korea, Republic of
Seoul, Korea, Republic of
Singapore, Singapore
Taipei, Taiwan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
  More Information

Responsible Party: Daiichi Sankyo Co., Ltd. Identifier: NCT00806624     History of Changes
Other Study ID Numbers: DU176b-C-J226
Study First Received: December 10, 2008
Results First Received: January 15, 2015
Last Updated: January 15, 2015

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017