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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DU-176b | Experimental | DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| edoxaban | Drug |
| ||
| enoxaparin sodium |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Fuji | Osaka Koseinenkin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27980462 | Derived | 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. | |
| 27284271 |
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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/
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | DU-176b | DU-176b oral tablets, 30 mg., taken once daily for 2 weeks edoxaban |
| FG001 | Enoxaparin Sodium | enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks enoxaparin sodium |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number of baseline participants reflects the efficacy analysis population
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| ID | Title | Description |
|---|---|---|
| BG000 | DU-176b | DU-176b oral tablets, 30 mg., taken once daily for 2 weeks edoxaban |
| BG001 | Enoxaparin Sodium | enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks enoxaparin sodium |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.
| Efficacy Analysis population. 22 (7.4%) - DU-176b 41 (13.9%) - enoxaparin | Posted | Number | 95% Confidence Interval | percent of participants with VTE events | 2 weeks |
|
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The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DU-176b | DU-176b oral tablets, 30 mg., taken once daily for 2 weeks edoxaban |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postoperative wound infection | Infections and infestations | MedDRA JV12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wound haemorrhage | Vascular disorders | MedDRA JV12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kei Ibusuki, Associate Director | Daiichi Sankyo.,LTD | 81-90-2732-9505 | ibusuki.kei.tx@daiichisankyo.co.jp |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D013927 | Thrombosis |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
| C000711671 | enoxaparin sodium |
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|
| Tokyo |
| Japan |
| Kaohsiung City | Taiwan |
| 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. |
| 25294589 | 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. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Enoxaparin Sodium | enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks enoxaparin sodium |
|
|
|
| Secondary | Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. | The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment | Posted | Number | 95% Confidence Interval | percentage of subjects with bleeds | 2 weeks |
|
|
|
|
| 10 |
| 354 |
| 237 |
| 354 |
| EG001 | Enoxaparin Sodium | enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks enoxaparin sodium | 11 | 349 | 256 | 349 |
| stitch abcess | Infections and infestations | MedDRA JV12.0 | Systematic Assessment |
|
| carotid artery stenosis | Nervous system disorders | MedDRA JV12.0 | Systematic Assessment |
|
| cerebellar infarction | Nervous system disorders | MedDRA JV12.0 | Systematic Assessment |
|
| convulsion | Nervous system disorders | MedDRA JV12.0 | Systematic Assessment |
|
| syncope | Nervous system disorders | MedDRA JV12.0 | Systematic Assessment |
|
| retinal artery occlusion | Eye disorders | MedDRA JV12.0 | Systematic Assessment |
|
| cyanosis | Cardiac disorders | MedDRA JV12.0 | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | MedDRA JV12.0 | Systematic Assessment |
|
| hypotension | Vascular disorders | MedDRA JV12.0 | Systematic Assessment |
|
| deep vein thrombosis | Vascular disorders | MedDRA JV12.0 | Systematic Assessment |
|
| gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA JV12.0 | Systematic Assessment |
|
| melaena | Gastrointestinal disorders | MedDRA JV12.0 | Systematic Assessment |
|
| pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA JV12.0 | Systematic Assessment |
|
| urticaria | Skin and subcutaneous tissue disorders | MedDRA JV12.0 | Systematic Assessment |
|
| haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA JV12.0 | Systematic Assessment |
|
| joint contracture | Musculoskeletal and connective tissue disorders | MedDRA JV12.0 | Systematic Assessment |
|
| pyrexia | General disorders | MedDRA JV12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA JV12.0 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA JV12.0 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA JV12.0 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA JV12.0 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA JV12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| blood urine present | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA JV12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA JV12.0 | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | MedDRA JV12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA JV12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA JV12.0 | Systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA JV12.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA JV12.0 | Systematic Assessment |
|
PI shall not publish the results of the Study at any time without the prior written approval of Sponsor.