CompletedNCT01203072Updated Feb 25, 2019Results posted

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

A Phase 2 interventional study of DU-176b and DU-176b in Venous Thromboembolism, Deep Vein Thrombosis and Total Knee Arthroplasty, sponsored by Daiichi Sankyo Co., Ltd.. Completed at 2 sites in Japan. Open to participants aged 20 Years to 84 Years. Per ClinicalTrials.gov, last updated 2019-02-25.

Sponsored by Daiichi Sankyo Co., Ltd. · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 523
Allocation: Randomized
Ages: 20 Years to 84 Years
Sex: All

Study summary

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

Conditions studied

Venous Thromboembolism
Deep Vein Thrombosis
Total Knee Arthroplasty

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Keywords

prevention
venous thromboembolism
edoxaban
factor Xa

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 523 is above the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Daiichi Sankyo Co., Ltd. is the lead sponsor of 72 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 84 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients undergoing unilateral total knee arthroplasty

Exclusion criteria

Exclusion Criteria:

risks of hemorrhage
thromboembolic risks
weight less than 40 kg
pregnant, suspect pregnancy, or subjects who want to become pregnant

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 523 participants (actual)

Study arms

Experimental
DU-176b 5 mg
Drug: DU-176b
Experimental
DU-176b 15 mg
Drug: DU-176b
Experimental
DU-176b 30 mg
Drug: DU-176b
Experimental
DU-176b 60 mg
Drug: DU-176b
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugDU-176b
DU-176b 5mg tablets oral, once daily for 2 weeks
Also known as: edoxaban
DrugDU-176b
DU-176b 15mg tablets, oral once daily for 2 weeks
Also known as: edoxaban
DrugDU-176b
DU-176b 30 mg tablets, oral, once daily for 2 weeks
Also known as: edoxaban
DrugDU-176b
DU-176b 60 mg tablets, oral, once daily for 2 weeks
Also known as: edoxaban
DrugPlacebo
Matching placebo oral tablets, once daily for 2 weeks

What researchers measure

Primary outcomes

Proportion 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 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
Time frame: 2 weeks

Secondary outcomes

Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug
Time frame: 2 weeks

Results

Posted Jan 26, 2015

Participant flow

Participant flow — Overall Study
Milestone	DU-176b 5 mg	DU-176b 15 mg	DU-176b 30 mg	DU-176b 60 mg	Placebo
Started	105	106	104	106	102
Completed	95	100	101	100	96
Not completed	10	6	3	6	6
Withdrew: Adverse event	5	3	2	4	2
Withdrew: Lack of efficacy	1	0	0	0	0
Withdrew: Lost to follow-up	0	1	0	0	0
Withdrew: Protocol violation	2	0	0	0	1
Withdrew: Withdrawal by subject	2	2	1	2	3

Outcome measures

PrimaryProportion 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 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

Time frame:: 2 weeks
Reported as:: Number · percentage of participants

Proportion of Subjects With Venous Thromboembolism Events.
percentage of participants	DU-176b 5 mg	DU-176b 15 mg	DU-176b 30 mg	DU-176b 60 mg	Placebo
Proportion of Subjects With Venous Thromboembolism Events.	29.5 (20.0 to 39.1)	26.1 (17.1 to 35.1)	12.5 (5.6 to 19.4)	9.1 (3.1 to 15.1)	48.3 (37.9 to 58.7)

Statistical analysis

DU-176b 5 mg vs DU-176b 15 mg vs DU-176b 30 mg vs DU-176b 60 mg vs Placebo · Cochran-Armitage · p = <0.001 (Significance level for Cochran-Armitage test and comparison using Shirley-Williams method was set at one-sided, 0.025. For other tests, significance level and confidence coefficient were set at two-sided, 0.05 and 0.95, respectively, unless specified)

SecondaryIncidence of Major Bleeding or Clinically Relevant Non-major Bleeding

Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. Related to the study drug

Time frame:: 2 weeks
Reported as:: Number · percentage of subjects with bleeds

Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding
percentage of subjects with bleeds	DU-176b 5 mg	DU-176b 15 mg	DU-176b 30 mg	DU-176b 60 mg	Placebo
Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding	1.9 (0.5 to 6.8)	3.8 (1.5 to 9.3)	3.9 (1.5 to 9.6)	4.7 (2.0 to 10.6)	3.9 (1.5 to 9.7)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
DU-176b 5 mg	—	2/103 (1.9%)	78/103 (75.7%)
DU-176b 15 mg	—	1/106 (0.9%)	85/106 (80.2%)
DU-176b 30 mg	—	1/103 (1%)	78/103 (75.7%)
DU-176b 60 mg	—	3/106 (2.8%)	78/106 (73.6%)
Placebo	—	5/102 (4.9%)	67/102 (65.7%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	DU-176b 5 mg	DU-176b 15 mg	DU-176b 30 mg	DU-176b 60 mg	Placebo
vertigo positionalEar and labyrinth disorders	0/103	0/106	0/103	0/106	1/102
rectal haemorrhageGastrointestinal disorders	0/103	0/106	0/103	0/106	1/102
platelet count decreasedInvestigations	0/103	0/106	0/103	0/106	1/102
tibia fractureInjury, poisoning and procedural complications	0/103	0/106	0/103	0/106	1/102
ligament ruptureInjury, poisoning and procedural complications	0/103	0/106	0/103	0/106	1/102
myocardial infarctionCardiac disorders	0/103	0/106	1/103	0/106	0/102
pyrexiaGeneral disorders	1/103	0/106	0/103	0/106	0/102
compression fractureInjury, poisoning and procedural complications	1/103	0/106	0/103	0/106	0/102
nasopharyngitisInfections and infestations	0/103	0/106	0/103	1/106	0/102
asthmaRespiratory, thoracic and mediastinal disorders	0/103	0/106	0/103	1/106	0/102

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	DU-176b 5 mg	DU-176b 15 mg	DU-176b 30 mg	DU-176b 60 mg	Placebo
blood lactate dehydrogenase increasedInvestigations	13/103	17/106	16/103	16/106	12/102
blood urine presentInvestigations	6/103	9/106	9/103	15/106	6/102
platelet count increasedInvestigations	9/103	14/106	12/103	6/106	5/102
blood alkaline phosphate increasedInvestigations	11/103	12/106	9/103	11/106	9/102
gamma glutamyltransferase increasedInvestigations	10/103	10/106	7/103	11/106	7/102
nasopharyngitisInfections and infestations	7/103	9/106	10/103	4/106	8/102
alanine aminotransferase increasedInvestigations	7/103	7/106	7/103	6/106	8/102
insomniaPsychiatric disorders	2/103	4/106	8/103	4/106	5/102
diarrheaGastrointestinal disorders	7/103	3/106	5/103	4/106	7/102
heamorrhage subcutaneousSkin and subcutaneous tissue disorders	1/103	4/106	7/103	5/106	4/102

Baseline characteristics

Age, Continuous
Age, Continuous(years)	DU-176b 5 mg	DU-176b 15 mg	DU-176b 30 mg	DU-176b 60 mg	Placebo	Total
Mean	70.2 ± 7.7	71.7 ± 7.0	71.6 ± 8.1	72.1 ± 7.0	70.3 ± 6.5	71.2 ± 7.3

Sex: Female, Male
Sex: Female, Male(Participants)	DU-176b 5 mg	DU-176b 15 mg	DU-176b 30 mg	DU-176b 60 mg	Placebo	Total
Female	67	74	69	69	68	347
Male	21	18	19	19	21	98

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	DU-176b 5 mg	DU-176b 15 mg	DU-176b 30 mg	DU-176b 60 mg	Placebo	Total
American Indian or Alaska Native	0	0	0	0	0	0
Asian	88	92	88	88	89	445
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0
White	0	0	0	0	0	0
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	DU-176b 5 mg	DU-176b 15 mg	DU-176b 30 mg	DU-176b 60 mg	Placebo	Total
Japan	88	92	88	88	89	445

Study locations

2 sites

Osaka, Japan
Tokyo, Japan

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01203072
Lead sponsor: Daiichi Sankyo Co., Ltd.
Responsible party: Sponsor
First posted: Sep 16, 2010
Start date: Jul 2006
Primary completion: Sep 2007
Completion: Jul 2008
Results posted: Jan 26, 2015
Last update: Feb 25, 2019

Study contacts

Takeshi Fuji, Director

principal investigator · Osaka Koseinekin Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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