Cancer Venous Thromboembolism (VTE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02073682
First received: February 25, 2014
Last updated: May 8, 2015
Last verified: May 2015

February 25, 2014
May 8, 2015
March 2015
December 2017   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT02073682 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Cancer Venous Thromboembolism (VTE)
Not Provided

Edoxaban will be similar to dalteparin in preventing recurrence of acute VTE following an initial index event in cancer subjects.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Venous Thromboembolism (VTE)
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Cancer
  • Drug: edoxaban
  • Drug: Dalteparin
  • Experimental: edoxaban group
    edoxaban
    Intervention: Drug: edoxaban
  • Active Comparator: dalteparin group
    dalteparin
    Intervention: Drug: Dalteparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
December 2017   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact: Lee Schwocho, PhD 7325905019 lschwocho@dsi.com
Contact: Claire McIver +353 18195409 Claire.McIver@quintiles.com
United States
 
NCT02073682
DU176b-D-U311, 2014-004708-30
Yes
Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP