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Cancer Venous Thromboembolism (VTE)

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ClinicalTrials.gov Identifier: NCT02073682
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

February 25, 2014
February 27, 2014
September 26, 2018
October 24, 2018
October 24, 2018
July 16, 2015
September 15, 2017   (Final data collection date for primary outcome measure)
Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event [ Time Frame: 12 months ]
  • 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
  • Number of Participants With Adjudicated Major Bleeding Events While on Treatment [ Time Frame: 12 months ]
    The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug).
  • Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period [ Time Frame: 12 months ]
  • Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period [ Time Frame: 12 months ]
  • Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period [ Time Frame: 12 months ]
  • Number of Participants With VTE-Related Death [ Time Frame: 12 months ]
  • Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death [ Time Frame: 12 months ]
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
The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.
Not Provided
Interventional
Phase 3
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
    After the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.
    Other Name: DU-176b
  • Drug: Dalteparin
    Dalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.
    Other Name: Active comparator
  • Drug: Low molecular weight heparin
    Therapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.
    Other Name: LMWH
  • Experimental: Edoxaban group
    After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
    Interventions:
    • Drug: Edoxaban
    • Drug: Low molecular weight heparin
  • Active Comparator: Dalteparin group
    Participants receive Dalteparin treatment daily -solution for subcutaneous injection
    Intervention: Drug: Dalteparin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1046
Not Provided
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, Older Adult)
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 https://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/Study-Sponsors-DS.aspx
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all 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, the European Union and/or Japan 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/Study-Sponsors-DS.aspx
Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
Not Provided
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
September 2018

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