Cancer Venous Thromboembolism (VTE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 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: October 13, 2014
Last verified: October 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

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 Enrollment: 1000
Study Start Date: March 2015
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: October 13, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
New Zealand: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Germany: Federal Institute for Drugs and Medical Devices
Austria: Austrian Medicines and Medical Devices Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Czech Republic: Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Hungary: Ministry of Health, Social and Family Affairs
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on October 23, 2014