Venous ThromboembolismPhase 2NCT01203072

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

A Phase 2 study testing DU-176b in people with Venous Thromboembolism and Deep Vein Thrombosis, run by Daiichi Sankyo Co., Ltd. at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 84 years
Conditions the study is for: Venous Thromboembolism, Deep Vein Thrombosis, Total Knee Arthroplasty
What is being tested?: DU-176b
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 523 participants
Where: 2 sitesJapan
Study dates: Jul 2006to Jul 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 84 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing unilateral total knee arthroplasty

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Study site
Osaka
Study site
Tokyo

Other trials in Japan

About this study

Official title: A Phase 2b, Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Dose-finding Study of the Oral Factor Xa Inhibitor DU-176b Compared With Placebo for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS J-1)

Conditions: Venous Thromboembolism, Deep Vein Thrombosis, Total Knee Arthroplasty
Being tested: DU-176b, Placebo
Keywords: prevention, venous thromboembolism, edoxaban, factor Xa
Medical subject headings: Venous Thromboembolism, Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DU-176bDrug
Also called edoxaban
DU-176b 5mg tablets oral, once daily for 2 weeks
DU-176bDrug
Also called edoxaban
DU-176b 15mg tablets, oral once daily for 2 weeks
DU-176bDrug
Also called edoxaban
DU-176b 30 mg tablets, oral, once daily for 2 weeks
DU-176bDrug
Also called edoxaban
DU-176b 60 mg tablets, oral, once daily for 2 weeks
PlaceboDrug
Matching placebo oral tablets, once daily for 2 weeks

Study groups in NCT01203072
Study group	Role	What they receive
DU-176b 5 mg	Experimental	Not described Receives: Drug: DU-176b
DU-176b 15 mg	Experimental	Not described Receives: Drug: DU-176b
DU-176b 30 mg	Experimental	Not described Receives: Drug: DU-176b
DU-176b 60 mg	Experimental	Not described Receives: Drug: DU-176b
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 weeks

Secondary outcomes (1)

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
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2006Jul 2008

First posted16 Sep 2010 (estimated)
Study startJul 2006
Primary completionSep 2007
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 523 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01203072
Sponsor's protocol ID: DU176b-04
Status last verified: Jan 2015
First submitted: 14 Sep 2010
Last updated: 25 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: 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/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
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All Venous Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Randomized, Double-Blind, Multi-Dose Efficacy, Safety and Dose-finding Study of the Oral Factor Xa Inhibitor DU-176b Compared With Placebo for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS J-1)
ClinicalTrials.gov ID: NCT01203072
Acronym / sponsor ID: DU176b-04
Conditions: Venous Thromboembolism, Deep Vein Thrombosis, Total Knee Arthroplasty
Keywords: prevention, venous thromboembolism, edoxaban, factor Xa
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 523 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Sep 2007 (actual)
Study completion: Jul 2008 (actual)
First posted: 16 Sep 2010 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

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

Who may qualify

Ages: 20 to 84 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients undergoing unilateral total knee arthroplasty

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DU-176bAlso: edoxabanDU-176b 5mg tablets oral, once daily for 2 weeks	Drug	DU-176b 5 mg
DU-176bAlso: edoxabanDU-176b 15mg tablets, oral once daily for 2 weeks	Drug	DU-176b 15 mg
DU-176bAlso: edoxabanDU-176b 30 mg tablets, oral, once daily for 2 weeks	Drug	DU-176b 30 mg
DU-176bAlso: edoxabanDU-176b 60 mg tablets, oral, once daily for 2 weeks	Drug	DU-176b 60 mg
PlaceboMatching placebo oral tablets, once daily for 2 weeks	Drug	Placebo

Primary outcome

Proportion of Subjects With Venous Thromboembolism Events.
Time frame: 2 weeks
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

1 secondary outcome

Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding
Time frame: 2 weeks

Results and safety

Results posted to the registry on 26 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DU-176b 5 mg	105	95
DU-176b 15 mg	106	100
DU-176b 30 mg	104	101
DU-176b 60 mg	106	100
Placebo	102	96

Primary outcome: Proportion of Subjects With Venous Thromboembolism Events.

Time frame: 2 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	DU-176b 5 mg n = 88	DU-176b 15 mg n = 92	DU-176b 30 mg n = 88	DU-176b 60 mg n = 88	Placebo n = 89
Value	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)

DU-176b 5 mg vs DU-176b 15 mg vs DU-176b 30 mg vs DU-176b 60 mg vs Placebo: p <0.001, Cochran-Armitage

Population analysed: The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DU-176b 5 mg	2 of 103 (1.9%)	78 of 103 (75.7%)	Not reported
DU-176b 15 mg	1 of 106 (0.9%)	85 of 106 (80.2%)	Not reported
DU-176b 30 mg	1 of 103 (1%)	78 of 103 (75.7%)	Not reported
DU-176b 60 mg	3 of 106 (2.8%)	78 of 106 (73.6%)	Not reported
Placebo	5 of 102 (4.9%)	67 of 102 (65.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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/

Related trials for Venous Thromboembolism

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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RecruitingPhase 3
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RecruitingPhase 3
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Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Takeshi Fuji, Director principal investigator

Osaka Koseinekin Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DU-176b in people with Venous Thromboembolism and Deep Vein Thrombosis, run by Daiichi Sankyo Co., Ltd. at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Subjects With Venous Thromboembolism Events. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01203072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.