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Study of DU-176b Aged 80 Years or Older

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: NCT02801669
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular NVAF aged 80 years or older who are ineligible for available oral anticoagulation therapy.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Du-176b Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 984 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of DU-176b in Patients With NVAF Aged 80 Years or Older Who Are Ineligible for Available Oral Anticoagulation Therapy
Actual Study Start Date : August 5, 2016
Actual Primary Completion Date : December 27, 2019
Actual Study Completion Date : May 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DU-176b 15 mg group
DU-176b orally administered at a dose of 15 mg once daily.
Drug: Du-176b
DU-176b orally administered at a dose of 15 mg once daily.
Other Name: edoxaban

Placebo Comparator: Placebo group
Placebo orally administered once daily.
Drug: placebo
Placebo orally administered once daily.




Primary Outcome Measures :
  1. Composite of stroke and systemic embolic events (SEE) [ Time Frame: treatment and follow-up for up to 2.5 years ]
    Composite of stroke and systemic embolic events (SEE) Treatment and follow-up for 2-2.5 years



Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy

Exclusion Criteria:

  • Patients with active bleeding
  • Patients who have poorly controlled hypertension
  • Patients who have liver dysfunction accompanied with disorder of blood coagulation

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): NCT02801669


Locations
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Japan
Social Corporation Keigakukai Minamiosaka Hospital
Osaka-city, Osaka, Japan, 559-0012
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02801669    
Other Study ID Numbers: DU176b-C-J316
163266 ( Registry Identifier: JAPIC CTI )
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
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/
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
anticoagulants
DU-176b
edoxaban
factor Xa
oral
prevention
atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Edoxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants