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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 hip 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. |
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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.
| 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. | Posted | Number | 95% Confidence Interval | percentage of subjects with vte events | 2 weeks |
|
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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 |
|---|---|---|---|---|---|
| deep vein thrombosis | Vascular disorders | MedDRA/JV.12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspartate aminotransferase increased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Masayuki Fukuzawa, Associate Director | Daiichi Sankyo Co., Ltd. | 81-90-5584-2197 | fukuzawa.masayuki.gn@daiichisankyo.co.jp |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D013923 | Thromboembolism |
| D013927 | Thrombosis |
| D004617 | Embolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
| C000711671 | enoxaparin sodium |
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|
| Tokyo |
| Japan |
| Physician Decision |
|
| Protocol Violation |
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| 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 |
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| Region of Enrollment | Number | participants |
|
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks edoxaban |
| 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 | Safety analyses were performed for the Safety Analysis Set, which was defined as all subjects who were secondarily enrolled in the study, but excluded those who had significant GCP violations, who had not received 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 |
|
|
|
| 9 |
| 303 |
| 197 |
| 303 |
| EG001 | Enoxaparin Sodium | enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks enoxaparin sodium | 9 | 301 | 232 | 301 |
| femur fracture | Injury, poisoning and procedural complications | MedDRA/JV.12.0 | Systematic Assessment |
|
| pelvic fracture | Injury, poisoning and procedural complications | MedDRA/JV.12.0 | Systematic Assessment |
|
| herpes zoster | Infections and infestations | MedDRA/JV.12.0 | Systematic Assessment |
|
| otrhostatic hypotension | Vascular disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA/JV.12.0 | Systematic Assessment |
|
| lacunar infarction | Nervous system disorders | MedDRA/JV.12.0 | Systematic Assessment |
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| intestinal obstruction | Gastrointestinal disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| postoperative wound infection | Infections and infestations | MedDRA/JV.12.0 | Systematic Assessment |
|
| hip fracture | Injury, poisoning and procedural complications | MedDRA/JV.12.0 | Systematic Assessment |
|
| abcess jaw | Infections and infestations | MedDRA/JV.12.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| gastroenteritis | Gastrointestinal disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
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| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA/JV.12.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
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| headache | Nervous system disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA/JV.12.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
PI shall not publish the results of the Study at any time without the prior written approval of Sponsor.