Back to resultsDU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
Primary Purpose
Atrial Fibrillation, Stroke
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
DU-176b tablets
DU-176b tablets
Warfarin tablets
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
2
3
1
Arm Description
DU-176b tablets: high-dose
Warfarin tablets
DU-176b tablets: low-dose
Outcomes
Primary Outcome Measures
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.
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
Evaluation of Effects on Biomarkers of Thrombus Formation
Evaluation of Plasma Concentration of DU-176
Evaluation of Effects on Pharmacodynamic Biomarkers
Evaluation of All Clinical and Laboratory Safety Data.
Full Information
NCT ID
NCT00806624
First Posted
December 10, 2008
Last Updated
February 8, 2019
Sponsor
Daiichi Sankyo Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00806624
Brief Title
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
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 Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Experimental
Arm Description
DU-176b tablets: high-dose
Arm Title
3
Arm Type
Active Comparator
Arm Description
Warfarin tablets
Arm Title
1
Arm Type
Experimental
Arm Description
DU-176b tablets: low-dose
Intervention Type
Drug
Intervention Name(s)
DU-176b tablets
Intervention Description
DU-176b tablets taken once daily for up to 3 months
Intervention Type
Drug
Intervention Name(s)
DU-176b tablets
Intervention Description
DU-176b tablets taken once daily for up to 3 months
Intervention Type
Drug
Intervention Name(s)
Warfarin tablets
Intervention Description
Warfarin tablets taken once daily for up to 3 months
Primary Outcome Measure Information:
Title
Incidence of All Bleeding
Description
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 Outcome Measure Information:
Title
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
Title
Evaluation of Effects on Biomarkers of Thrombus Formation
Time Frame
6 months
Title
Evaluation of Plasma Concentration of DU-176
Time Frame
6 months
Title
Evaluation of Effects on Pharmacodynamic Biomarkers
Time Frame
6 months
Title
Evaluation of All Clinical and Laboratory Safety Data.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Hong-Kong
Country
China
City
Seoul
Country
Korea, Republic of
City
Singapore
Country
Singapore
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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/
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Learn more about this trial
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
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