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Cancer Venous Thromboembolism (VTE)

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. Identifier:
First received: February 25, 2014
Last updated: October 14, 2016
Last verified: October 2016
Edoxaban will be similar to dalteparin in preventing recurrence of acute VTE following an initial index event in cancer subjects.

Condition Intervention Phase
Venous Thromboembolism (VTE) Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Cancer Drug: edoxaban Drug: Dalteparin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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

Primary Outcome Measures:
  • incidence of recurrent VTE at end of study [ Time Frame: 6 months ]
    primary efficacy outcome is incidence of recurrent VTE at end of study

  • incidence of of clinically relevant bleeding while on treatment [ Time Frame: 6 months ]
    primary safety outcome is incidence of clinically relevant bleeding while on treatment

Estimated Enrollment: 1000
Study Start Date: March 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: edoxaban group
Drug: edoxaban
Active Comparator: dalteparin group
Drug: Dalteparin


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

Inclusion Criteria:

  • Male or female subjects with age ≥ 18 years or the otherwise legal lower age according to the country of residence;
  • Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
  • Cancer, other than basal-cell or squamous-cell carcinoma of the skin;
  • Able to provide written informed consent.

Exclusion Criteria:

  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
  • Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
  • Active bleeding or high risk for bleeding contraindicating treatment with LMWH or edoxaban;
  • Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or edoxaban;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02073682

Contact: Lee Schwocho, PhD 7325905019
Contact: Claire McIver +353 18195409

United States, Florida
Brandon, Florida, United States
United States, Georgia
Jonesboro, Georgia, United States
United States, Michigan
Detroit, Michigan, United States
United States, Virginia
Norfolk, Virginia, United States
Leuven, Vlaams-Brabant, Belgium
Saint-Etienne cedex 2, France
Debrecen, Hajdu-Bihar megye, Hungary
Varese, Italy
Amsterdam, Netherlands
Sponsors and Collaborators
Daiichi Sankyo, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT02073682     History of Changes
Other Study ID Numbers: DU176b-D-U311
2014-004708-30 ( EudraCT Number )
Study First Received: February 25, 2014
Last Updated: October 14, 2016

Additional relevant MeSH terms:
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heparin, Low-Molecular-Weight
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents processed this record on August 16, 2017