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CompletedPhase 3NCT02073682
Official study title

Cancer Venous Thromboembolism (VTE)

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEdoxaban and Dalteparin

Plus 1 other study approaches.

Who it may be forRecurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 6, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?9 U.S. locations

Locations may change over time.

Who runs it?Daiichi Sankyo

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Daiichi Sankyo
Interventions being studied
Drug: Edoxaban; Drug: Dalteparin; Drug: Low molecular weight heparin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting
Recurrent or relapsed→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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;

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Study locationBrandon, Florida
  • Study locationJonesboro, Georgia
  • Study locationDetroit, Michigan
  • Study locationNorfolk, Virginia
  • Study locationLeuven, Vlaams-Brabant
  • Study locationSaint-Etienne
  • Study locationDebrecen, Hajdu-Bihar Megye
  • Study locationVarese
  • Study locationAmsterdam

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 6, 2019. Always confirm current availability with the study team.

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