Trial record 5 of 770 for:    "Venous Thrombosis"

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).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00986154
First received: September 25, 2009
Last updated: June 20, 2014
Last verified: July 2013
  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 3

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:


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 ]

Enrollment: 8292
Study Start Date: October 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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

  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
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: NCT00986154

  Show 447 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):
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: June 20, 2014
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:
Venous Thrombosis
Venous Thromboembolism
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
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 August 19, 2014