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Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.
The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15mg BID | Experimental | 15mg edoxaban administered twice daily (BID) |
|
| 30mg QD | Experimental | 30mg edoxaban administered once daily (QD) |
|
| 30mg BID | Experimental | 30mg edoxaban administered twice daily (BID) |
|
| 60mg QD | Experimental | 60mg edoxaban administered once daily (QD) |
|
| 60mg BID | Experimental | 60mg edoxaban administered twice daily (BID) |
|
| 120mg QD | Experimental | 120mg edoxaban administered once daily (QD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DU-176b | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of Venous Thromboembolism (VTE) | 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 (approximately 2 weeks post surgery). Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for Prothrombin Time (PT) Results | Intent to Treat (ITT) population | end of treatment |
| Change From Baseline for International Normalized Ratio (INR) Results | Intent to Treat (ITT) population |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Decatur | Georgia | 30033 | United States |
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 | 15mg BID | 15mg edoxaban administered twice daily (BID) |
| FG001 | 30mg QD | 30mg edoxaban administered once daily (QD) |
| FG002 | 30mg BID | 30mg edoxaban administered twice daily (BID) |
| FG003 | 60mg QD | 60mg edoxaban administered once daily (QD) |
| FG004 | 60mg BID | 60mg edoxaban administered twice daily (BID) |
| FG005 | 120mg QD | 120mg edoxaban administered once daily (QD) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 15mg BID | 15mg edoxaban administered twice daily (BID) |
| BG001 | 30mg QD | 30mg edoxaban administered once daily (QD) |
| 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 | Prevention of Venous Thromboembolism (VTE) | 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 (approximately 2 weeks post surgery). Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography | modified ITT population | Posted | Number | 90% Confidence Interval | percentage of patients with event | 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 | 15mg BID | 15mg edoxaban administered twice daily (BID) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| obstructive inguinal hernia | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tachycardia | Cardiac disorders | MedDRA (8.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victor Fernandez | Daiichi Sankyo, Inc. | 732-590-5000 | vfernandez@dsi.com |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
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| end of treatment |
| Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results | Intent to Treat (ITT) population | end of treatment |
| Death |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Administrative Reasons |
|
| BG002 | 30mg BID | 30mg edoxaban administered twice daily (BID) |
| BG003 | 60mg QD | 60mg edoxaban administered once daily (QD) |
| BG004 | 60mg BID | 60mg edoxaban administered twice daily (BID) |
| BG005 | 120mg QD | 120mg edoxaban administered once daily (QD) |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 30mg QD |
30mg edoxaban administered once daily (QD) |
| OG002 | 30mg BID | 30mg edoxaban administered twice daily (BID) |
| OG003 | 60mg QD | 60mg edoxaban administered once daily (QD) |
| OG004 | 60mg BID | 60mg edoxaban administered twice daily (BID) |
| OG005 | 120mg QD | 120mg edoxaban administered once daily (QD) |
|
|
|
| Secondary | Change From Baseline for Prothrombin Time (PT) Results | Intent to Treat (ITT) population | ITT population | Posted | Mean | Standard Deviation | seconds | end of treatment |
|
|
|
| Secondary | Change From Baseline for International Normalized Ratio (INR) Results | Intent to Treat (ITT) population | ITT population | Posted | Mean | Standard Deviation | INR ratio | end of treatment |
|
|
|
| Secondary | Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results | Intent to Treat (ITT) population | ITT population | Posted | Mean | Standard Deviation | seconds | end of treatment |
|
|
|
| 4 |
| 85 |
| 24 |
| 85 |
| EG001 | 30mg QD | 30mg edoxaban administered once daily (QD) | 3 | 75 | 19 | 75 |
| EG002 | 30mg BID | 30mg edoxaban administered twice daily (BID) | 9 | 129 | 65 | 129 |
| EG003 | 60mg QD | 60mg edoxaban administered once daily (QD) | 10 | 99 | 56 | 99 |
| EG004 | 60mg BID | 60mg edoxaban administered twice daily (BID) | 10 | 115 | 66 | 115 |
| EG005 | 120mg QD | 120mg edoxaban administered once daily (QD) | 4 | 103 | 34 | 103 |
| dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| haematoma | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
|
| wound infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA (8.1) | Systematic Assessment |
|
| postoperative wound infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| haemoglobin decreased | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| hip fracture | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| thrombocytopenia | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
|
| blood alkaline phosphatase abnormal | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| alanine aminotransferase abnormal | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| blood bilirubin abnormal | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| aspartate amniotransferase abnormal | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| rectal haemorrhage | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| hepatic enzyme increase | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| sciatic nerve palsy | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| snake bite | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| contrast media reaction | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| wound haemorrhage | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
|
| postprocedural fistula | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| acute psychosis | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| anemia postoperative | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| lymphadentis | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
|
| infection | Infections and infestations | MedDRA (8.1) | Systematic Assessment |
|
| hip arthroplasty | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| alanine aminotransferase increase | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| blood alkaline phosphatase increase | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
|
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| pancreatitis | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| tremor | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| anxiety | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Systematic Assessment |
|
| pallor | Vascular disorders | MedDRA (8.1) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (8.1) | Systematic Assessment |
|
| hyperthermia | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| oedema peripheral | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| pyrexia | General disorders | MedDRA (8.1) | Systematic Assessment |
|
| procedural pain | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
| activated partial thromboplastin time prolonged | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| prothrombin time prolonged | Investigations | MedDRA (8.1) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (8.1) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA (8.1) | Systematic Assessment |
|
| anaemia | Blood and lymphatic system disorders | MedDRA (8.1) | Systematic Assessment |
|
| anaemia post-operative | Injury, poisoning and procedural complications | MedDRA (8.1) | Systematic Assessment |
|
A study site may not publish results of a study until after a coordinated multicenter publication has been submitted for publication or until one year after the study has ended, whichever occurs first. The study site will have the opportunity to publish results of the study, provided Daiichi Sankyo has had the opportunity to review and comment on the study site's proposed publication prior to being submitted for publication with the advice of patent council and need for subject protection.