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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00806624
First received: December 10, 2008
Last updated: February 11, 2010
Last verified: February 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Evaluation of effects on biomarkers of thrombus formation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Evaluation of plasma concentration of DU-176 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluation of effects on pharmacodynamic biomarkers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Evaluation of all clinical and laboratory safety data. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 235
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806624

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

No publications provided

Responsible Party: Associate Manager, Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT00806624     History of Changes
Other Study ID Numbers: DU176b-C-J226
Study First Received: December 10, 2008
Last Updated: February 11, 2010
Health Authority: Taiwan: Department of Health
Korea: Food and Drug Administration
Hong Kong: Department of Health
Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013