Cancer Venous Thromboembolism (VTE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02073682
First received: February 25, 2014
Last updated: April 13, 2016
Last verified: April 2016
  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 Study Completion Date: December 2017
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   (Adult, Senior)
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073682

Contacts
Contact: Lee Schwocho, PhD 7325905019 lschwocho@dsi.com
Contact: Claire McIver +353 18195409 Claire.McIver@quintiles.com

Locations
United States, Florida
Recruiting
Brandon, Florida, United States
United States, Georgia
Recruiting
Jonesboro, Georgia, United States
United States, Michigan
Recruiting
Detroit, Michigan, United States
United States, Virginia
Recruiting
Norfolk, Virginia, United States
Belgium
Recruiting
Leuven, Vlaams-Brabant, Belgium
France
Recruiting
Saint-Etienne cedex 2, France
Hungary
Recruiting
Debrecen, Hajdu-Bihar megye, Hungary
Italy
Recruiting
Varese, Italy
Netherlands
Recruiting
Amsterdam, Netherlands
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT02073682     History of Changes
Other Study ID Numbers: DU176b-D-U311  2014-004708-30 
Study First Received: February 25, 2014
Last Updated: April 13, 2016
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:
Thrombosis
Thromboembolism
Embolism
Venous Thromboembolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Edoxaban
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2016