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The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus 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 30mg once daily | Experimental | DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery |
|
| Enoxaparin sodium twice daily | Active Comparator | Enoxaparin sodium 20mg (=2000IU) / 0.2mL twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery |
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| DU-176b 15mg once daily | Experimental | DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DU-176b 15mg | Drug | DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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 Bleedings. | 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 |
|---|---|---|---|
| 25047458 | Derived | Fuji T, Wang CJ, Fujita S, Kawai Y, Kimura T, Tachibana S. Safety and efficacy of edoxaban, an oral factor xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan. J Arthroplasty. 2014 Dec;29(12):2439-46. doi: 10.1016/j.arth.2014.05.029. Epub 2014 Jun 9. |
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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 15 mg | DU-176b 15 mg tablets, oral once daily for 2 weeks |
| FG001 | DU-176b 30 mg | DU-176b 30 mg tablets oral, once daily for 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| DU-176b 30mg | Drug | DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery. |
|
|
| Enoxaparin sodium 20 mg (=2000IU) | Drug | Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery. |
|
| Tokyo |
| Japan |
| Kaohsiung City | Taiwan |
| FG002 | Enoxaparin Sodium 20mg (2000IU) | Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks |
| Safety Analysis Dataset |
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| COMPLETED |
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| NOT COMPLETED |
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Number of baseline participants reflects the efficacy analysis population
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| ID | Title | Description |
|---|---|---|
| BG000 | DU-176b 15 mg | DU-176b 15 mg tablets, oral once daily for 2 weeks |
| BG001 | DU-176b 30 mg | DU-176b 30 mg tablets oral, once daily for 2 weeks |
| BG002 | Enoxaparin Sodium 20mg (2000IU) | Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage 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 | percent of participants with VTE event | 2 weeks |
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| Secondary | Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings. | 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 |
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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 15 mg | DU-176b 15 mg tablets, oral once daily for 2 weeks | 1 | 89 | 58 | 89 | ||
| EG001 | DU-176b 30 mg | DU-176b 30 mg tablets oral, once daily for 2 weeks | 2 | 85 | 60 | 85 | ||
| EG002 | Enoxaparin Sodium 20mg (2000IU) | Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks | 1 | 87 | 72 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dislocation of joint prothesis | Injury, poisoning and procedural complications | MedDRA/J V.11.1 | Systematic Assessment |
| |
| vertigo positional | Injury, poisoning and procedural complications | MedDRA/J V.11.1 | Systematic Assessment |
| |
| colitis | Gastrointestinal disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA/J V.11.1 | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| alanine aminotransferase increased | Investigations | MedDRA/J V.11.1 | Systematic Assessment |
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| aspartate aminotransferase increased | Investigations | MedDRA/J V.11.1 | Systematic Assessment |
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| gamma glutamyltransferase | Investigations | MedDRA/J V.11.1 | Systematic Assessment |
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| blood urine present | Investigations | MedDRA/J V.11.1 | Systematic Assessment |
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| blood alkaline phosphatase increased | Investigations | MedDRA/J V.11.1 | Systematic Assessment |
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| dizziness | Nervous system disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| headache | Nervous system disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| eczema | Skin and subcutaneous tissue disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| pruritis | Skin and subcutaneous tissue disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| blood triglycerides increased | Investigations | MedDRA/J V.11.1 | Systematic Assessment |
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| abdominal pain upper | Gastrointestinal disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| stomach discomfort | Gastrointestinal disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | MedDRA/J V.11.1 | Systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | MedDRA/J V.11.1 | Systematic Assessment |
| |
| skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA/J V.11.1 | Systematic Assessment |
| |
| blood lactate dehydrogenase increased | Investigations | MedDRA/J V.11.1 | Systematic Assessment |
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PI shall not publish the results of the Study at any time without the prior written approval of Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Masayuki Fukuzawa, Associate Director | Daiichi Sankyo.,LTD | 81-90-5584-2197 | fukuzawa.masayuki.gn@daiichisankyo.co.jp |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D013923 | Thromboembolism |
| D013927 | Thrombosis |
| 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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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Japan |
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| Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated. | Cox Proportional Hazard | 1.1 | 2-Sided | 95 | -4.6 | 6.8 | Superiority or Other |
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