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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00633893
Registration number
NCT00633893
Ethics application status
Date submitted
5/03/2008
Date registered
12/03/2008
Date last updated
25/11/2013
Titles & IDs
Public title
Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
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Scientific title
A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism
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Secondary ID [1]
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0
EUDRACT: 2007-004953-27
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Secondary ID [2]
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0
CV185-057
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis
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0
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
0
0
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0
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Clotting disorders
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Respiratory
0
0
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0
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Other respiratory disorders / diseases
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Cardiovascular
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0
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - Placebo
Experimental: 1 - 2.5 mg
Experimental: 2 - 5.0 mg
Active Comparator: 3 - 0 mg
Treatment: Drugs: Apixaban
Tablets, Oral, twice daily, 12 months
Treatment: Drugs: Placebo
Tablets, Oral, twice daily, 12 months
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
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Assessment method [1]
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VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.
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Timepoint [1]
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Day 1 up to 12 Months
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Primary outcome [2]
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Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
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Assessment method [2]
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VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.
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Timepoint [2]
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Day 1 up to 12 months
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Secondary outcome [1]
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0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation
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Assessment method [1]
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VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.
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Timepoint [1]
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0
Day 1 up to 12 Months
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Secondary outcome [2]
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0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation
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Assessment method [2]
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0
VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.
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Timepoint [2]
0
0
Day 1 up to 12 Months
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Secondary outcome [3]
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Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation
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Assessment method [3]
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DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.
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Timepoint [3]
0
0
Day 1 up to 12 Months
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Secondary outcome [4]
0
0
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation
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Assessment method [4]
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PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
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Timepoint [4]
0
0
Day 1 up to 12 Months
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Secondary outcome [5]
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Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation
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Assessment method [5]
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VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).
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Timepoint [5]
0
0
Day 1 up to 12 Months
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Secondary outcome [6]
0
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Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation
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Assessment method [6]
0
0
CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
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Timepoint [6]
0
0
Day 1 up to 12 Months
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Secondary outcome [7]
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Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
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Assessment method [7]
0
0
DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
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Timepoint [7]
0
0
Day 1 up to 12 Months
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Secondary outcome [8]
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Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation
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Assessment method [8]
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All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.
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Timepoint [8]
0
0
Day 1 up to 12 Months
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Secondary outcome [9]
0
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Adjudicated Major Bleeding During the Treatment Period - Treated Population
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Assessment method [9]
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Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
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Timepoint [9]
0
0
Day 1 up to 12 Months
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Secondary outcome [10]
0
0
Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
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Assessment method [10]
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0
Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
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Timepoint [10]
0
0
Day 1 up to 12 Months
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Secondary outcome [11]
0
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Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
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Assessment method [11]
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Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.
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Timepoint [11]
0
0
Day 1 up to 12 months
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Secondary outcome [12]
0
0
Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants
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Assessment method [12]
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0
All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
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Timepoint [12]
0
0
Day 1 up to 12 months
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Secondary outcome [13]
0
0
Adjudicated Total Bleeding During the Treatment Period - Treated Participants
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Assessment method [13]
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All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.
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Timepoint [13]
0
0
Day 1 up to 12 months
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Secondary outcome [14]
0
0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation
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Assessment method [14]
0
0
VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.
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Timepoint [14]
0
0
Day 1 up to 12 Months
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Secondary outcome [15]
0
0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation
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Assessment method [15]
0
0
CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.
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Timepoint [15]
0
0
Day 1 up to 12 Months
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Secondary outcome [16]
0
0
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation
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Assessment method [16]
0
0
DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
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Timepoint [16]
0
0
Day 1 up to 12 Months
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Secondary outcome [17]
0
0
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation
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Assessment method [17]
0
0
PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
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Timepoint [17]
0
0
Day 1 up to 12 Months
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Secondary outcome [18]
0
0
Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation
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Assessment method [18]
0
0
VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.
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Timepoint [18]
0
0
Day 1 up to 12 Months
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Secondary outcome [19]
0
0
Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation
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Assessment method [19]
0
0
CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
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Timepoint [19]
0
0
Day 1 up to 12 Months
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Secondary outcome [20]
0
0
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
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Assessment method [20]
0
0
DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.
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Timepoint [20]
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Day 1 up to 12 Months
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Eligibility
Key inclusion criteria
- Men and women = 18 years of age;
- Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
- Anticoagulant treatment completed
- No recurrence of Venous Thromboembolism (VTE)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects with indications for long-term treatment with a vitamin K antagonist
- Active bleeding or high risk for serious bleeding
- Short life expectancy
- Uncontrolled high blood pressure
- Impaired kidney or liver function
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2012
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Sample size
Target
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Accrual to date
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Final
2711
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
0
0
Local Institution - Garran
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Recruitment hospital [2]
0
0
Local Institution - Kogarah
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Recruitment hospital [3]
0
0
Local Institution - Lismore
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Recruitment hospital [4]
0
0
Local Institution - St Leonards
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Recruitment hospital [5]
0
0
Local Institution - Herston
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Recruitment hospital [6]
0
0
Local Institution - Kippa Ring
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Recruitment hospital [7]
0
0
Local Institution - Woolloongabba
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Recruitment hospital [8]
0
0
Local Institution - Adelaide
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Recruitment hospital [9]
0
0
Local Institution - Bedford Park
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Recruitment hospital [10]
0
0
Local Institution - Launceston
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Recruitment hospital [11]
0
0
Local Institution - Box Hill
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Recruitment hospital [12]
0
0
Local Institution - Clayton
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Recruitment hospital [13]
0
0
Local Institution - Footscray
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Recruitment hospital [14]
0
0
Local Institution - Parkville
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Recruitment hospital [15]
0
0
Local Institution - Richmond
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Recruitment hospital [16]
0
0
Local Institution - Ringwood East
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Recruitment hospital [17]
0
0
Local Institution - Windsor
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Recruitment hospital [18]
0
0
Local Institution - Perth
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Recruitment postcode(s) [1]
0
0
2605 - Garran
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Recruitment postcode(s) [2]
0
0
2217 - Kogarah
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Recruitment postcode(s) [3]
0
0
2480 - Lismore
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Recruitment postcode(s) [4]
0
0
2065 - St Leonards
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Recruitment postcode(s) [5]
0
0
4029 - Herston
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Recruitment postcode(s) [6]
0
0
4021 - Kippa Ring
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Recruitment postcode(s) [7]
0
0
4102 - Woolloongabba
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Recruitment postcode(s) [8]
0
0
5000 - Adelaide
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Recruitment postcode(s) [9]
0
0
5042 - Bedford Park
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Recruitment postcode(s) [10]
0
0
7250 - Launceston
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Recruitment postcode(s) [11]
0
0
3128 - Box Hill
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Recruitment postcode(s) [12]
0
0
3168 - Clayton
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Recruitment postcode(s) [13]
0
0
3011 - Footscray
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Recruitment postcode(s) [14]
0
0
3050 - Parkville
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Recruitment postcode(s) [15]
0
0
3121 - Richmond
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Recruitment postcode(s) [16]
0
0
3135 - Ringwood East
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Recruitment postcode(s) [17]
0
0
3181 - Windsor
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Recruitment postcode(s) [18]
0
0
6000 - Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Arkansas
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Country [4]
0
0
United States of America
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State/province [4]
0
0
California
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Colorado
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Delaware
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Idaho
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maine
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Montana
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Nebraska
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oklahoma
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Rhode Island
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
South Carolina
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Tennessee
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Texas
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Utah
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Virginia
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Washington
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Wisconsin
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Buenos Aires
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Santa Fe
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Cordoba
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Corrientes
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Graz
Query!
Country [38]
0
0
Austria
Query!
State/province [38]
0
0
Innsbruck
Query!
Country [39]
0
0
Austria
Query!
State/province [39]
0
0
Vienna
Query!
Country [40]
0
0
Austria
Query!
State/province [40]
0
0
Wien
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Bahia
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Distrito Federal
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Minas Gerais
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Parana
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Rio De Janeiro
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Rio Grande Do Sul
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Sao Paulo
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Alberta
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
British Columbia
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Ontario
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Quebec
Query!
Country [52]
0
0
Chile
Query!
State/province [52]
0
0
Araucania
Query!
Country [53]
0
0
Chile
Query!
State/province [53]
0
0
Magallanes Antartica
Query!
Country [54]
0
0
Chile
Query!
State/province [54]
0
0
Metropolitana
Query!
Country [55]
0
0
Chile
Query!
State/province [55]
0
0
Valparaiso
Query!
Country [56]
0
0
Czech Republic
Query!
State/province [56]
0
0
Kladno
Query!
Country [57]
0
0
Czech Republic
Query!
State/province [57]
0
0
Litomysl
Query!
Country [58]
0
0
Czech Republic
Query!
State/province [58]
0
0
Mestec Kralove
Query!
Country [59]
0
0
Czech Republic
Query!
State/province [59]
0
0
Ostrava Vitkovice
Query!
Country [60]
0
0
Czech Republic
Query!
State/province [60]
0
0
Plzen
Query!
Country [61]
0
0
Czech Republic
Query!
State/province [61]
0
0
Praha 13
Query!
Country [62]
0
0
Czech Republic
Query!
State/province [62]
0
0
Praha 1
Query!
Country [63]
0
0
Czech Republic
Query!
State/province [63]
0
0
Praha 2
Query!
Country [64]
0
0
Czech Republic
Query!
State/province [64]
0
0
Praha 4
Query!
Country [65]
0
0
Czech Republic
Query!
State/province [65]
0
0
Usti Nad Orlici
Query!
Country [66]
0
0
Denmark
Query!
State/province [66]
0
0
Arhus C
Query!
Country [67]
0
0
Denmark
Query!
State/province [67]
0
0
Braedstrup
Query!
Country [68]
0
0
Denmark
Query!
State/province [68]
0
0
Esbjerg
Query!
Country [69]
0
0
Denmark
Query!
State/province [69]
0
0
Frederiksberg
Query!
Country [70]
0
0
Denmark
Query!
State/province [70]
0
0
Hellerup
Query!
Country [71]
0
0
Denmark
Query!
State/province [71]
0
0
Herning
Query!
Country [72]
0
0
Denmark
Query!
State/province [72]
0
0
Hilleroed
Query!
Country [73]
0
0
Denmark
Query!
State/province [73]
0
0
Naestved
Query!
Country [74]
0
0
Denmark
Query!
State/province [74]
0
0
Silkeborg
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Arras
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Besancon
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Brest Cedex
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Clamart
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Clermont-Ferrand Cedex 01
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Dijon
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Grenoble
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Le Kremlin-Bicetre
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Lille Cedex
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Limoges Cedex
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Lyon Cedex 03
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Nantes
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Saint-Priest En Jarez
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Toulouse Cedex 9
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Vernon
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Berlin
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Bochum
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Bonn
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Cologne
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Dortmund
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Dresden
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Erfurt
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Frankfurt
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Gottingen
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Karlsbad
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Krefeld
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Ludwigshafen
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Mannheim
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Munchen
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Munich
Query!
Country [105]
0
0
Hong Kong
Query!
State/province [105]
0
0
Hong Kong
Query!
Country [106]
0
0
Hong Kong
Query!
State/province [106]
0
0
Shatin, N.T
Query!
Country [107]
0
0
India
Query!
State/province [107]
0
0
Andhra Pradesh
Query!
Country [108]
0
0
India
Query!
State/province [108]
0
0
Gujarat
Query!
Country [109]
0
0
India
Query!
State/province [109]
0
0
Haryana
Query!
Country [110]
0
0
India
Query!
State/province [110]
0
0
Karnataka
Query!
Country [111]
0
0
India
Query!
State/province [111]
0
0
Kerala
Query!
Country [112]
0
0
India
Query!
State/province [112]
0
0
Maharashtra
Query!
Country [113]
0
0
India
Query!
State/province [113]
0
0
Punjab
Query!
Country [114]
0
0
India
Query!
State/province [114]
0
0
Tagore Nagar
Query!
Country [115]
0
0
India
Query!
State/province [115]
0
0
Tamil Nadu
Query!
Country [116]
0
0
India
Query!
State/province [116]
0
0
Ahmedabad
Query!
Country [117]
0
0
India
Query!
State/province [117]
0
0
Bangalore, Karnataka
Query!
Country [118]
0
0
India
Query!
State/province [118]
0
0
Bangalore
Query!
Country [119]
0
0
India
Query!
State/province [119]
0
0
Chennai
Query!
Country [120]
0
0
India
Query!
State/province [120]
0
0
New Dehli
Query!
Country [121]
0
0
Israel
Query!
State/province [121]
0
0
Afula
Query!
Country [122]
0
0
Israel
Query!
State/province [122]
0
0
Givataim
Query!
Country [123]
0
0
Israel
Query!
State/province [123]
0
0
Hadera
Query!
Country [124]
0
0
Israel
Query!
State/province [124]
0
0
Haifa
Query!
Country [125]
0
0
Israel
Query!
State/province [125]
0
0
Holon
Query!
Country [126]
0
0
Israel
Query!
State/province [126]
0
0
Jerusalem
Query!
Country [127]
0
0
Israel
Query!
State/province [127]
0
0
Kfar Saba
Query!
Country [128]
0
0
Israel
Query!
State/province [128]
0
0
Kiryat Hadassah
Query!
Country [129]
0
0
Israel
Query!
State/province [129]
0
0
Nahariya
Query!
Country [130]
0
0
Israel
Query!
State/province [130]
0
0
Petach-Tikva
Query!
Country [131]
0
0
Israel
Query!
State/province [131]
0
0
Safed
Query!
Country [132]
0
0
Israel
Query!
State/province [132]
0
0
Tel Aviv
Query!
Country [133]
0
0
Israel
Query!
State/province [133]
0
0
Tel Hashomer
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Bollate
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Bologna
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Chieti Scalo
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Cosenza
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Ferrara
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Firenze
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Genova
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Milano
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Padova
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Palermo
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Pavia
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Perugia
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Piacenza
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Pisa
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Roma
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Rozzano (Mi)
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
San Daniele Del Friuli (Ud)
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Udine
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Venezia
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Vicenza
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Vittorio Veneto (Tv)
Query!
Country [155]
0
0
Korea, Republic of
Query!
State/province [155]
0
0
Busan
Query!
Country [156]
0
0
Korea, Republic of
Query!
State/province [156]
0
0
Jongno-Gu
Query!
Country [157]
0
0
Korea, Republic of
Query!
State/province [157]
0
0
Seoul
Query!
Country [158]
0
0
Mexico
Query!
State/province [158]
0
0
Baja California
Query!
Country [159]
0
0
Mexico
Query!
State/province [159]
0
0
Distrito Federal
Query!
Country [160]
0
0
Mexico
Query!
State/province [160]
0
0
Guanajuato
Query!
Country [161]
0
0
Mexico
Query!
State/province [161]
0
0
Jalisco
Query!
Country [162]
0
0
Mexico
Query!
State/province [162]
0
0
Nuevo Leon
Query!
Country [163]
0
0
Mexico
Query!
State/province [163]
0
0
Sinaloa
Query!
Country [164]
0
0
Mexico
Query!
State/province [164]
0
0
Veracruz
Query!
Country [165]
0
0
Mexico
Query!
State/province [165]
0
0
Aguascalientes
Query!
Country [166]
0
0
Mexico
Query!
State/province [166]
0
0
Chihuahua
Query!
Country [167]
0
0
Mexico
Query!
State/province [167]
0
0
Durango
Query!
Country [168]
0
0
Mexico
Query!
State/province [168]
0
0
Puebla
Query!
Country [169]
0
0
Mexico
Query!
State/province [169]
0
0
Queretaro
Query!
Country [170]
0
0
Mexico
Query!
State/province [170]
0
0
San Luis Potosi
Query!
Country [171]
0
0
Norway
Query!
State/province [171]
0
0
Alesund
Query!
Country [172]
0
0
Norway
Query!
State/province [172]
0
0
Fredrikstad
Query!
Country [173]
0
0
Norway
Query!
State/province [173]
0
0
Gjettum
Query!
Country [174]
0
0
Norway
Query!
State/province [174]
0
0
Gjovik
Query!
Country [175]
0
0
Norway
Query!
State/province [175]
0
0
Hamar
Query!
Country [176]
0
0
Norway
Query!
State/province [176]
0
0
Oslo
Query!
Country [177]
0
0
Philippines
Query!
State/province [177]
0
0
Cavite
Query!
Country [178]
0
0
Philippines
Query!
State/province [178]
0
0
Davao City
Query!
Country [179]
0
0
Philippines
Query!
State/province [179]
0
0
Pasig City
Query!
Country [180]
0
0
Philippines
Query!
State/province [180]
0
0
Quezon City
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
0
0
Arkonska 4
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Bialystok
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Bydgoszcz
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Gdansk
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Gdynia
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Lodz
Query!
Country [187]
0
0
Poland
Query!
State/province [187]
0
0
Lublin
Query!
Country [188]
0
0
Poland
Query!
State/province [188]
0
0
Poznan
Query!
Country [189]
0
0
Poland
Query!
State/province [189]
0
0
Przeworsk
Query!
Country [190]
0
0
Poland
Query!
State/province [190]
0
0
Szczecin
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Tarnobrzeg
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
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0
Warsawa
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Country [193]
0
0
Poland
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State/province [193]
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0
Warsaw
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Country [194]
0
0
Poland
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State/province [194]
0
0
Warszawa
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Country [195]
0
0
Poland
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State/province [195]
0
0
Wroclaw
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Country [196]
0
0
Portugal
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State/province [196]
0
0
Guarda
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Country [197]
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Portugal
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State/province [197]
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Lisboa
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Country [198]
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Puerto Rico
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San Juan
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Country [199]
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Romania
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Baia Mare
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Romania
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Bucharest
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Country [201]
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Romania
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Targu Mures
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Country [202]
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Russian Federation
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Arkhangelsk
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Country [203]
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Rostov-On Don
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Russian Federation
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Ryazan
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Country [208]
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Russian Federation
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Saint Petersburg
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Country [209]
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Russian Federation
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Saint-Petersburg
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Country [210]
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Russian Federation
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Samara
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Country [211]
0
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Russian Federation
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State/province [211]
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Saratov
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Country [212]
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Russian Federation
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State/province [212]
0
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St Petersburg
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Country [213]
0
0
Russian Federation
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State/province [213]
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Tomsk
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Country [214]
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0
Russian Federation
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State/province [214]
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Yaroslavl
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Country [215]
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Singapore
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Singapore
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Country [216]
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South Africa
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Free State
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South Africa
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Gauteng
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Country [218]
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South Africa
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State/province [218]
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0
Kwa Zulu Natal
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Country [219]
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South Africa
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State/province [219]
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Western Cape
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Country [220]
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Spain
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State/province [220]
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Alicante
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Country [221]
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Spain
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Barcelona
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Country [222]
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Spain
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Madrid
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Country [223]
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Spain
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State/province [223]
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Cadiz
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Country [224]
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Spain
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Getafe
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Country [225]
0
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Spain
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State/province [225]
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Girona
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Country [226]
0
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Spain
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State/province [226]
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0
L'Hospitalet De Llobregat
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Country [227]
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Spain
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State/province [227]
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Leon
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Country [228]
0
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Spain
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State/province [228]
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Mourente
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Country [229]
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Spain
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State/province [229]
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Pamplona
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Country [230]
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Spain
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State/province [230]
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Salamanca
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Country [231]
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Spain
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State/province [231]
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Sant Boi De Llobregat
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Country [232]
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Spain
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State/province [232]
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Tarragona
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Country [233]
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Spain
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State/province [233]
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Toledo
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Country [234]
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Spain
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State/province [234]
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Valencia
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Country [235]
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Ukraine
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State/province [235]
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Chernihiv
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Country [236]
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Ukraine
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State/province [236]
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Dnipropetrovsk
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Country [237]
0
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Ukraine
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State/province [237]
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Donetsk
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Country [238]
0
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Ukraine
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State/province [238]
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Ivano-Frankivsk
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Country [239]
0
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Ukraine
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State/province [239]
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Kharkiv
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Country [240]
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Ukraine
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State/province [240]
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Kyiv
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Country [241]
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Ukraine
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Lviv
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Country [242]
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Ukraine
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State/province [242]
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Odesa
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Country [243]
0
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Ukraine
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State/province [243]
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Ternopil
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Country [244]
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Ukraine
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Vinnytsia
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Country [245]
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Ukraine
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Zaporizhzhia
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Country [246]
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United Kingdom
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State/province [246]
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Aberdeenshire
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Country [247]
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United Kingdom
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State/province [247]
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Essex
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Country [248]
0
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United Kingdom
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State/province [248]
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Greater London
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Country [249]
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United Kingdom
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State/province [249]
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Greater Manchester
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Country [250]
0
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United Kingdom
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State/province [250]
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Humberside
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Country [251]
0
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United Kingdom
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State/province [251]
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Nottinghamshire
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Country [252]
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United Kingdom
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State/province [252]
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Suffolk
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Country [253]
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United Kingdom
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State/province [253]
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West Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Pfizer
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in
preventing venous thromboembolic (VTE) recurrence or death in patients who have completed
their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00633893
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Public notes
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Contacts
Principal investigator
Name
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0
Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00633893
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