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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01203098
First received: September 14, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

The objective of this study is to compare the efficacy, safety at each dose versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.


Condition Intervention Phase
Anticoagulants
Venous Thromboembolism
Thromboembolism
Thrombosis
Enoxaparin Sodium
Embolism and Thrombosis
Deep Vein Thrombosis
DU-176b
Edoxaban
Factor Xa
Oral
Arthroplasty, Replacement, Hip
Drug: DU-176V 15 mg tablets oral, once daily for 2 weeks
Drug: DU-176b 30 mg tablets, oral once daily for 2 weeks
Drug: Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous
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:
  • Proportion of subjects with venous thromboembolism events [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with bleeding events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 263
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 30 mg Drug: DU-176b 30 mg tablets, oral once daily for 2 weeks
Active Comparator: Enoxaparin sodium Drug: Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous
Experimental: DU-176b 15 mg Drug: DU-176V 15 mg tablets oral, once daily for 2 weeks

  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 Inc.
Daiichi Sankyo Co., Ltd.
Investigators
Principal Investigator: Takeshi Fuji Osaka Koseinenkin Hospital
  More Information

No publications provided

Responsible Party: Masayuki Fukuzawa, Daiichi Sankyo Tokyo, Ltd., Clinical Development Department I
ClinicalTrials.gov Identifier: NCT01203098     History of Changes
Other Study ID Numbers: DU176b-B-J209
Study First Received: September 14, 2010
Last Updated: September 14, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Embolism and Thrombosis
Thrombosis
Thromboembolism
Venous Thrombosis
Venous Thromboembolism
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
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 October 01, 2014