Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study). - Full Text View

Sponsor:	Daiichi Sankyo Inc.
Information provided by (Responsible Party):	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00986154

Purpose

Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

Condition	Intervention	Phase
Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism Thromboembolism Venous Thrombosis	Drug: edoxaban tosylate(DU-176b) Drug: low molecular weight heparin/unfractionated heparin Drug: warfarin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: Warfarin Warfarin sodium Warfarin potassium Heparin

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:

Symptomatic recurrent VTE, i.e., the composite of DVT, non-fatal PE, and fatal PE [ Time Frame: 12 months from time of randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The composite clinical outcome of symptomatic recurrent DVT, non-fatal symptomatic recurrent PE, and all-cause mortality [ Time Frame: 12 months from time of randomization ] [ Designated as safety issue: No ]
Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment [ Time Frame: 12 months from time of randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	7500
Study Start Date:	October 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: heparin/edoxaban tosylate	Drug: edoxaban tosylate(DU-176b) edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment Drug: low molecular weight heparin/unfractionated heparin LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily. Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
Active Comparator: heparin/warfarin	Drug: low molecular weight heparin/unfractionated heparin LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily. Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment Drug: warfarin tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment

Arms

Assigned Interventions

Experimental: heparin/edoxaban tosylate

Drug: edoxaban tosylate(DU-176b)

edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment

Drug: low molecular weight heparin/unfractionated heparin

LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.

Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment

Active Comparator: heparin/warfarin

Drug: low molecular weight heparin/unfractionated heparin

LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.

Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment

Drug: warfarin

tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment

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 older than the minimum legal adult age (country specific);
Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
Able to provide written informed consent

Exclusion Criteria:

thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
Calculated CrCL < 30 mL/min;
significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) >\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
concurrent treatment with potent P-gp inhibitors;
subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986154

Contacts

Contact: Jessica Cooper

919-998-2657

Show 332 Study Locations

Sponsors and Collaborators

Daiichi Sankyo Inc.

More Information

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Camm AJ, Bounameaux H. Edoxaban: a new oral direct factor xa inhibitor. Drugs. 2011 Aug 20;71(12):1503-26.

Responsible Party:	Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:	NCT00986154 History of Changes
Other Study ID Numbers:	DU176b-D-U305, The Edoxaban Hokusai VTE Study
Study First Received:	September 25, 2009
Last Updated:	September 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:

Recurrent Thrombosis
Recurrent Pulmonary Embolism
Symptomatic Deep Vein Thrombosis
Symptomatic Pulmonary Embolism
Venous Thromboembolism

Additional relevant MeSH terms:

Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium heparin

Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012