Cancer Venous Thromboembolism (VTE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02073682
First received: February 25, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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 3

Study Type: Interventional

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    primary safety outcome is incidence of clinically relevant bleeding while on treatment


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT02073682     History of Changes
Other Study ID Numbers: DU176b-D-U311
Study First Received: February 25, 2014
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Pulmonary Embolism
Thromboembolism
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Embolism
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 16, 2014