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Cancer Venous Thromboembolism (VTE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02073682
First Posted: February 27, 2014
Last Update Posted: October 13, 2017
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.
February 25, 2014
February 27, 2014
October 13, 2017
March 2015
September 15, 2017   (Final data collection date for primary outcome measure)
  • Number of participants with recurrent VTE at end of study [ Time Frame: 6 months ]
    Primary efficacy outcome is incidence of recurrent VTE at end of study
  • Number of participants with clinically relevant bleeding while on treatment [ Time Frame: 6 months ]
    Primary safety outcome is incidence of clinically relevant bleeding while on treatment
  • 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
Complete list of historical versions of study NCT02073682 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cancer Venous Thromboembolism (VTE)
A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
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
Intervention Model: Parallel Assignment
Masking: None (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
van Es N, Di Nisio M, Bleker SM, Segers A, Mercuri MF, Schwocho L, Kakkar A, Weitz JI, Beyer-Westendorf J, Boda Z, Carrier M, Chlumsky J, Décousus H, Garcia D, Gibbs H, Kamphuisen PW, Monreal M, Ockelford P, Pabinger I, Verhamme P, Grosso MA, Büller HR, Raskob GE. Edoxaban for treatment of venous thromboembolism in patients with cancer. Rationale and design of the Hokusai VTE-cancer study. Thromb Haemost. 2015 Nov 25;114(6):1268-76. doi: 10.1160/TH15-06-0452. Epub 2015 Aug 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1050
September 15, 2017
September 15, 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;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Hungary,   Italy,   Netherlands,   United States
 
 
NCT02073682
DU176b-D-U311
2014-004708-30 ( EudraCT Number )
Yes
Not Provided
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 http://www.clinicalstudydatarequest.com. 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://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both 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 and the European Union 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://www.clinicalstudydatarequest.com/Study-Sponsors-DS-Details.aspx
Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
Not Provided
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
October 2017

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