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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00806624
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : January 26, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( 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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Drug: DU-176b tablets Drug: Warfarin tablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Evaluation of Effects on Biomarkers of Thrombus Formation [ Time Frame: 6 months ]
  3. Evaluation of Plasma Concentration of DU-176 [ Time Frame: 6 months ]
  4. Evaluation of Effects on Pharmacodynamic Biomarkers [ Time Frame: 6 months ]
  5. Evaluation of All Clinical and Laboratory Safety Data. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806624


Locations
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China
Hong-Kong, China
Korea, Republic of
Seoul, Korea, Republic of
Singapore
Singapore, Singapore
Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT00806624    
Other Study ID Numbers: DU176b-C-J226
First Posted: December 11, 2008    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: February 26, 2019
Last Verified: January 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Edoxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action