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Cancer Venous Thromboembolism (VTE)

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thromboembolism (VTE); Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Cancer

Intervention: edoxaban (Drug); Dalteparin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Daiichi Sankyo Inc.

Overall contact:
Lee Schwocho, PhD, Phone: 7325905019, Email: lschwocho@dsi.com

Summary

Edoxaban will be similar to dalteparin in preventing recurrence of acute VTE following an initial index event in cancer subjects.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

incidence of recurrent VTE at end of study

incidence of of clinically relevant bleeding while on treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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;

Locations and Contacts

Lee Schwocho, PhD, Phone: 7325905019, Email: lschwocho@dsi.com

Saint-Etienne cedex 2, France; Recruiting

Varese, Italy; Recruiting

Amsterdam, Netherlands; Recruiting

Brandon, Florida, United States; Recruiting

Jonesboro, Georgia, United States; Recruiting

Debrecen, Hajdu-Bihar megye, Hungary; Recruiting

Detroit, Michigan, United States; Recruiting

Norfolk, Virginia, United States; Recruiting

Leuven, Vlaams-Brabant, Belgium; Recruiting

Additional Information

Starting date: March 2015
Last updated: July 23, 2015

Page last updated: August 20, 2015

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