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 : March 6, 2019
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Condition or disease | Intervention/treatment | Phase |
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Venous Thromboembolism (VTE) Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Cancer | Drug: Edoxaban Drug: Dalteparin Drug: Low molecular weight heparin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1046 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 16, 2015 |
Actual Primary Completion Date : | September 15, 2017 |
Actual Study Completion Date : | September 15, 2017 |

Arm | Intervention/treatment |
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Experimental: Edoxaban group
After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use
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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: 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 |
Active Comparator: Dalteparin group
Participants receive Dalteparin treatment daily -solution for subcutaneous injection
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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 |
- Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event [ Time Frame: 12 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073682
United States, Florida | |
Brandon, Florida, United States | |
United States, Georgia | |
Jonesboro, Georgia, United States | |
United States, Michigan | |
Detroit, Michigan, United States | |
United States, Virginia | |
Norfolk, Virginia, United States | |
Belgium | |
Leuven, Vlaams-Brabant, Belgium | |
France | |
Saint-Etienne cedex 2, France | |
Hungary | |
Debrecen, Hajdu-Bihar Megye, Hungary | |
Italy | |
Varese, Italy | |
Netherlands | |
Amsterdam, Netherlands |
Study Director: | Global Clinical Leader | Daiichi Sankyo, Inc. |
Documents provided by Daiichi Sankyo, Inc.:
Responsible Party: | Daiichi Sankyo, Inc. |
ClinicalTrials.gov Identifier: | NCT02073682 |
Other Study ID Numbers: |
DU176b-D-U311 2014-004708-30 ( EudraCT Number ) |
First Posted: | February 27, 2014 Key Record Dates |
Results First Posted: | October 24, 2018 |
Last Update Posted: | March 6, 2019 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
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://vivli.org/. 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://vivli.org/ourmember/daiichi-sankyo/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
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://vivli.org/ourmember/daiichi-sankyo/ |
Active Cancer with Metastasis |
Pulmonary Embolism Thrombosis Embolism Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Heparin Heparin, Low-Molecular-Weight |
Tinzaparin Dalteparin Edoxaban Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |