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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DU-176b 5 mg | Experimental |
| |
| DU-176b 15 mg | Experimental |
| |
| DU-176b 30 mg | Experimental |
| |
| DU-176b 60 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DU-176b | Drug | DU-176b 5mg tablets oral, once daily for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Fuji, Director | Osaka Koseinekin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan | |||||
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 5 mg | DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks |
| FG001 | DU-176b 15 mg | DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks |
| FG002 | DU-176b 30 mg | DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks |
| FG003 | DU-176b 60 mg | DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks |
| FG004 | Placebo | Placebo: Matching placebo oral tablets, once daily for 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DU-176b 5 mg | DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks |
| BG001 | DU-176b 15 mg | DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks |
| 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 | 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.
| 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 participants | 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 5 mg | DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA/JV.12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA/JV.12.0 | 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 |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
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| DU-176b | Drug | DU-176b 15mg tablets, oral once daily for 2 weeks |
|
|
| DU-176b | Drug | DU-176b 30 mg tablets, oral, once daily for 2 weeks |
|
|
| DU-176b | Drug | DU-176b 60 mg tablets, oral, once daily for 2 weeks |
|
|
| Placebo | Drug | Matching placebo oral tablets, once daily for 2 weeks |
|
| Tokyo |
| Japan |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | DU-176b 30 mg | DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks |
| BG003 | DU-176b 60 mg | DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks |
| BG004 | Placebo | Placebo: Matching placebo oral tablets, once daily for 2 weeks |
| BG005 | 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 |
|
DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks |
| OG001 | DU-176b 15 mg | DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks |
| OG002 | DU-176b 30 mg | DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks |
| OG003 | DU-176b 60 mg | DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks |
| OG004 | Placebo | Placebo: Matching placebo oral tablets, once daily for 2 weeks |
|
|
|
| Secondary | 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 | Safety Analysis Set is defined as subjects secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any doses of study drug, or had no safety data after start of study treatment. Subjects with significant GCP violations, but received at least one dose of study drug, safety data were assessed individually | Posted | Number | 95% Confidence Interval | percentage of subjects with bleeds | 2 weeks |
|
|
|
| 2 |
| 103 |
| 78 |
| 103 |
| EG001 | DU-176b 15 mg | DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks | 1 | 106 | 85 | 106 |
| EG002 | DU-176b 30 mg | DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks | 1 | 103 | 78 | 103 |
| EG003 | DU-176b 60 mg | DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks | 3 | 106 | 78 | 106 |
| EG004 | Placebo | Placebo: Matching placebo oral tablets, once daily for 2 weeks | 5 | 102 | 67 | 102 |
| vertigo positional | Ear and labyrinth disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| rectal haemorrhage | Gastrointestinal disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| pyrexia | General disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| platelet count decreased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
|
| compression fracture | Injury, poisoning and procedural complications | MedDRA/JV.12.0 | Systematic Assessment |
|
| joint dislocation | Injury, poisoning and procedural complications | MedDRA/JV.12.0 | Systematic Assessment |
|
| spinal compression fracture | Injury, poisoning and procedural complications | MedDRA/JV.12.0 | Systematic Assessment |
|
| tibia fracture | Injury, poisoning and procedural complications | MedDRA/JV.12.0 | Systematic Assessment |
|
| ligament rupture | Injury, poisoning and procedural complications | MedDRA/JV.12.0 | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| wound haemorrhage | Vascular disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| heamorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| pruritis | Skin and subcutaneous tissue disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| haematuria | Renal and urinary disorders | MedDRA/JV.12.0 | Systematic Assessment |
|
| alanine aminotransferase increased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
|
| aspartate aminotransferase increased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
|
| blood lactate dehydrogenase increased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
|
| gamma glutamyltransferase increased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
|
| blood urine present | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
|
| haemoglobin decreased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
|
| platelet count increased | Investigations | MedDRA/JV.12.0 | Systematic Assessment |
|
| blood alkaline phosphate increased | Investigations | 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.
| D013927 |
| Thrombosis |