A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

NCT01181102 | Completed Phase 3 Results DMC

• 1 other identifier: DU176b-B-J302
• Study Type: interventional
• Target: 716
• Locations: 2 countries
• Sites: 3

Brief Summary

The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Conditions

Venous Thromboembolism

Keywords

anticoagulant; venus thromboembolism; thrombosis; thromboembolism; embolism and thrombosis; deep vein thrombosis; DU-176b; Edoxaban; factor Xa; total knee arthroplasty; Enoxaparin sodium

Outcome Measures

Primary Outcomes (1)

• Incidence of Subjects With Venous Thromboembolism Events.

  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 Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment * Definite diagnosis of symptomatic Pulmonary Embolism (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 venous Thromboembolism (VTE)

  2 weeks

Secondary Outcomes (1)

• Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.

  2 weeks

Study Arms (2)

DU-176b

EXPERIMENTAL

DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery.

Drug: edoxaban

enoxaparin sodium

ACTIVE COMPARATOR

enoxaparin sodium 20mg (=2000IU) 0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.

Drug: enoxaparin sodium

Interventions

edoxaban DRUG

DU-176b

enoxaparin sodium DRUG

enoxaparin sodium

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral total knee arthroplasty

You may not qualify if:

• Subjects with risks of hemorrhage
• Subjects with thromboembolic risks
• Subjects who weigh less than 40 kg
• Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.

Sponsors & Collaborators

• Daiichi Sankyo Co., Ltd.: lead

Study Sites (3)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Related Publications (3)

• Kawai Y, Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S. Edoxaban versus enoxaparin for the prevention of venous thromboembolism after total knee or hip arthroplasty: pooled analysis of coagulation biomarkers and primary efficacy and safety endpoints from two phase 3 trials. Thromb J. 2016 Dec 1;14:48. doi: 10.1186/s12959-016-0121-1. eCollection 2016.

  PMID: 27980462 DERIVED

• Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S, Nakamura M. Clinical benefit of graduated compression stockings for prevention of venous thromboembolism after total knee arthroplasty: post hoc analysis of a phase 3 clinical study of edoxaban. Thromb J. 2016 Jun 8;14:13. doi: 10.1186/s12959-016-0087-z. eCollection 2016.

  PMID: 27284271 DERIVED

• Fuji T, Wang CJ, Fujita S, Kawai Y, Nakamura M, Kimura T, Ibusuki K, Ushida H, Abe K, Tachibana S. Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial. Thromb Res. 2014 Dec;134(6):1198-204. doi: 10.1016/j.thromres.2014.09.011. Epub 2014 Sep 21.

  PMID: 25294589 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Thrombosis; Thromboembolism; Embolism and Thrombosis; Venous Thrombosis

Interventions

edoxaban; enoxaparin sodium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kei Ibusuki, Associate Director
• Organization: Daiichi Sankyo.,LTD

ibusuki.kei.tx@daiichisankyo.co.jp

81-90-2732-9505

Study Officials

• Takeshi Fuji

  Osaka Koseinenkin Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 5, 2019
• Results First Posted: February 19, 2015

Record last verified: 2015-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

TW (1); JP (2)