A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01203098
First received: September 14, 2010
Last updated: February 6, 2015
Last verified: February 2015
  Purpose

The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.


Condition Intervention Phase
Venous Thromboembolism
Thromboembolism
Thrombosis
Embolism and Thrombosis
Deep Vein Thrombosis
Arthroplasty, Replacement, Hip
Drug: DU-176b 15mg
Drug: DU-176b 30mg
Drug: Enoxaparin sodium 20 mg (=2000IU)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Percentage of Subjects With Venous Thromboembolism Events [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.

    • Lower extremity DVT confirmed by bilateral venography at the end of study treatment
    • Definite diagnosis of symptomatic PE
    • Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE


Secondary Outcome Measures:
  • Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 264
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DU-176b 30mg once daily
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
Drug: DU-176b 30mg
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Other Name: edoxaban
Active Comparator: Enoxaparin sodium twice daily
Enoxaparin sodium 20mg (=2000IU) / 0.2mL twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery
Drug: Enoxaparin sodium 20 mg (=2000IU)
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.
Experimental: DU-176b 15mg once daily
DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
Drug: DU-176b 15mg
DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Other Name: edoxaban

  Eligibility

Ages Eligible for Study:   20 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing unilateral total hip arthroplasty
  2. Patients who are 20-84 years olds

Exclusion Criteria:

  1. Subjects with risks of hemorrhage
  2. Subjects with thromboembolic risks
  3. Subjects who weigh less than 40 kg
  4. Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant
  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: NCT01203098

Locations
Japan
Osaka, Japan
Tokyo, Japan
Taiwan
Kaohsiung, Taiwan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
Principal Investigator: Takeshi Fuji Osaka Koseinenkin Hospital
  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. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01203098     History of Changes
Other Study ID Numbers: DU176b-B-J209
Study First Received: September 14, 2010
Results First Received: January 15, 2015
Last Updated: February 6, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Daiichi Sankyo Inc.:
prevention
venous thromboembolism
edoxaban
anticoagulants

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Thromboembolism
Thrombosis
Cardiovascular Diseases
Vascular Diseases
Enoxaparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015