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Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00986154
First Posted: September 29, 2009
Last Update Posted: April 2, 2015
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.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
  Purpose
Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

Condition Intervention Phase
Venous Thromboembolism Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Thromboembolism Venous Thrombosis Drug: edoxaban tosylate(DU-176b) Drug: low molecular weight heparin/unfractionated heparin Drug: warfarin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE [ Time Frame: 12 months from time of randomization ]

    Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period.

    Overall Study Period defined as "The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."



Secondary Outcome Measures:
  • The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality [ Time Frame: 12 months from time of randomization ]
  • Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment [ Time Frame: 12 months from time of randomization ]
    Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.


Enrollment: 8292
Study Start Date: October 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: heparin/edoxaban tosylate Drug: edoxaban tosylate(DU-176b)
edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
Drug: low molecular weight heparin/unfractionated heparin

LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.

Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment

Active Comparator: heparin/warfarin Drug: low molecular weight heparin/unfractionated heparin

LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.

Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment

Drug: warfarin
tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects older than the minimum legal adult age (country specific);
  • Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
  • Able to provide written informed consent

Exclusion Criteria:

  • thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
  • More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
  • Calculated Creatinine clearance (CrCL) < 30 mL/min;
  • significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) >\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
  • patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
  • active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
  • chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
  • treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
  • concurrent treatment with potent P-gp inhibitors;
  • subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
  Contacts and Locations
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): NCT00986154


  Show 454 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00986154     History of Changes
Other Study ID Numbers: DU176b-D-U305
The Edoxaban Hokusai VTE Study
First Submitted: September 25, 2009
First Posted: September 29, 2009
Results First Submitted: February 5, 2015
Results First Posted: February 25, 2015
Last Update Posted: April 2, 2015
Last Verified: March 2015

Keywords provided by Daiichi Sankyo, Inc.:
Recurrent Thrombosis
Recurrent Pulmonary Embolism
Symptomatic Deep Vein Thrombosis
Symptomatic Pulmonary Embolism
Venous Thromboembolism (VTE)

Additional relevant MeSH terms:
Venous Thrombosis
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium heparin
Edoxaban
Heparin
Warfarin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors