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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

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ClinicalTrials.gov Identifier: NCT00504556
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : March 13, 2015
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Thromboembolism Drug: Edoxaban (DU-176b) Drug: warfarin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
DU-176b 30mg tablet once daily
Drug: Edoxaban (DU-176b)
30mg tablet once daily

Experimental: 2
DU-176b 60mg once daily
Drug: Edoxaban (DU-176b)
60mg tablet once daily

Experimental: 3
DU-176b 30mg b.i.d.
Drug: Edoxaban (DU-176b)
30mg tablet two times a day

Experimental: 4
DU-176b 60mg tablets two times a day
Drug: Edoxaban (DU-176b)
60mg tablet two times a day

Active Comparator: 5
warfarin tablets
Drug: warfarin
warfarin tablets




Primary Outcome Measures :
  1. Adjudicated Incidence of Bleeding Events [ Time Frame: 3 months ]
    Adjudicated Incidence of Bleeding Events during treatment period

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Effects on Biomarker D-dimer [ Time Frame: 3 months ]
    Mean (SD) change from baseline in D-dimer

  3. Effects on Biomarker Prothrombin Fragments [ Time Frame: 3 months ]
    Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)

  4. Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b [ Time Frame: 3 months ]
    Median (min, max) values of Cmin,ss; Cmax,ss

  5. Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b [ Time Frame: 3 months ]
    Median (min, max) values of AUCss

  6. 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.

  7. 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.

  8. 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.


  9. 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.

  10. 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.



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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:

  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

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): NCT00504556


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Sponsors and Collaborators
Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00504556     History of Changes
Other Study ID Numbers: DU176b-PRT018
First Posted: July 20, 2007    Key Record Dates
Results First Posted: March 13, 2015
Last Update Posted: January 10, 2019
Last Verified: March 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)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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/

Keywords provided by Daiichi Sankyo, Inc.:
Anti-coagulant
Non-valvular
Venous Thromboembolism
Prevention of Blood Clots
Atrial Fibrillation
Non-valvular atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Edoxaban
Warfarin
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action