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A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for 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: NCT00504556
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : March 13, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE July 18, 2007
First Posted Date  ICMJE July 20, 2007
Results First Submitted Date  ICMJE February 5, 2015
Results First Posted Date  ICMJE March 13, 2015
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE June 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • Adjudicated Incidence of Bleeding Events [ Time Frame: 3 months ]
    Adjudicated Incidence of Bleeding Events during treatment period
  • Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA) [ Time Frame: 3 months ]
    liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2007)
The primary objective of this study is to evaluate safety of fixed doses DU-176b compared to warfarin in subjects with atrial fibrillation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2015)
  • Incidence of Major Adverse Cardiac Events MACE) [ Time Frame: 3 months ]
    MACE is defined as the composite of stroke [ischemic or hemorrhagic], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition
  • Effects on Biomarker D-dimer [ Time Frame: 3 months ]
    Mean (SD) change from baseline in D-dimer
  • Effects on Biomarker Prothrombin Fragments [ Time Frame: 3 months ]
    Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)
  • Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b [ Time Frame: 3 months ]
    Median (min, max) values of Cmin,ss; Cmax,ss
  • Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b [ Time Frame: 3 months ]
    Median (min, max) values of AUCss
  • Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b [ Time Frame: Day 28 ]
    Mean (SD) change from baseline in biomarker anti-Factor Xa [FXa] activity on Day 28, 1-3 hours post dose.
  • Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b [ Time Frame: Day 28 ]
    Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.
  • Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b [ Time Frame: Day 28 ]
    Mean (SD) change from baseline in biomarker prothrombinase induced clotting time [PICT] on Day 28, 1-3 hours post dose. PICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition.
  • Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b [ Time Frame: Day 28 ]
    Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.
  • Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b [ Time Frame: Day 28 ]
    Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2007)
The secondary objectives are evaluate fixed dose regimens of DU176b with respect to major cardiac adverse events, and pharmacokinetic and pharmacodynamic properties of DU-176b.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation
Official Title  ICMJE A Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens of DU-176b in Subjects With Non- Valvular Atrial Fibrillation
Brief Summary This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation
  • Thromboembolism
Intervention  ICMJE
  • Drug: Edoxaban (DU-176b)
    30mg tablet once daily
  • Drug: Edoxaban (DU-176b)
    60mg tablet once daily
  • Drug: Edoxaban (DU-176b)
    30mg tablet two times a day
  • Drug: Edoxaban (DU-176b)
    60mg tablet two times a day
  • Drug: warfarin
    warfarin tablets
Study Arms  ICMJE
  • Experimental: 1
    DU-176b 30mg tablet once daily
    Intervention: Drug: Edoxaban (DU-176b)
  • Experimental: 2
    DU-176b 60mg once daily
    Intervention: Drug: Edoxaban (DU-176b)
  • Experimental: 3
    DU-176b 30mg b.i.d.
    Intervention: Drug: Edoxaban (DU-176b)
  • Experimental: 4
    DU-176b 60mg tablets two times a day
    Intervention: Drug: Edoxaban (DU-176b)
  • Active Comparator: 5
    warfarin tablets
    Intervention: Drug: warfarin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2010)
1146
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, 18 to 80 years old.
  2. Able to provide written informed consent.
  3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)
  4. A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2

Exclusion Criteria:

  1. Subjects with mitral valve disease or previous valvular heart surgery
  2. Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin
  3. Known or suspected hereditary or acquired bleeding or coagulation disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Belgium,   Bosnia and Herzegovina,   Canada,   Chile,   Latvia,   Mexico,   Moldova, Republic of,   Russian Federation,   Slovakia,   Ukraine,   United States
Removed Location Countries Argentina,   Croatia,   Czech Republic,   Estonia,   Former Serbia and Montenegro,   Germany,   Lithuania,   Peru,   Poland,   Spain,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00504556
Other Study ID Numbers  ICMJE DU176b-PRT018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP