Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03891524
Registration number
NCT03891524
Ethics application status
Date submitted
25/03/2019
Date registered
27/03/2019
Date last updated
15/07/2022
Titles & IDs
Public title
A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery
Query!
Scientific title
A Randomized, Open-Label, Study Drug-Dose Blind, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-70033093 (BMS-986177), an Oral Factor XIa Inhibitor, Versus Subcutaneous Enoxaparin in Subjects Undergoing Elective Total Knee Replacement Surgery
Query!
Secondary ID [1]
0
0
70033093THR2001
Query!
Secondary ID [2]
0
0
CR108600
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
AXIOMATIC-TKR
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Arthroplasty, Replacement, Knee
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-70033093 25 mg
Treatment: Drugs - JNJ-70033093 50 mg
Treatment: Drugs - JNJ-70033093 100 mg
Treatment: Drugs - JNJ-70033093 200 mg
Treatment: Drugs - Placebo
Treatment: Drugs - Enoxaparin 40 mg
Experimental: Group A: JNJ-70033093 25 mg + Placebo BID - Participants will receive JNJ-70033093 25 milligram (mg) (1*25 mg capsule) and 1 placebo capsule twice daily (BID), orally for 10 to 14 postoperative days.
Experimental: Group B: JNJ-70033093 50 mg BID - Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.
Experimental: Group C: JNJ-70033093 100 mg + Placebo BID - Participants will receive JNJ-70033093 100 mg (1*100 mg capsule) and 1 placebo capsule BID orally for 10 to 14 postoperative days.
Experimental: Group D: JNJ-70033093 200 mg BID - Participants will receive JNJ-70033093 200 mg (2*100 mg capsules) BID orally for 10 to 14 postoperative days.
Experimental: Group E: JNJ-70033093 25 mg Once Daily + Placebo - Participants will receive JNJ-70033093 25 mg (1*25 mg capsule) once daily and 1 placebo capsule in the morning and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
Experimental: Group F: JNJ-70033093 200 mg Once Daily + Placebo - Participants will receive JNJ-70033093 200 mg (2*100 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
Experimental: Group G: JNJ-70033093 50 mg once daily + Placebo - Participants will receive JNJ-70033093 50 mg (2*25 mg capsules in the morning) once daily and 2 placebo capsules in the evening, orally for 10 to 14 postoperative days.
Active Comparator: Group I: Enoxaparin 40 mg Once Daily - Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
Treatment: Drugs: JNJ-70033093 25 mg
Participants will receive JNJ-70033093 25 mg (1*25 mg capsule) BID (in Group A) or once daily (in Group E), orally for 10 to 14 postoperative days.
Treatment: Drugs: JNJ-70033093 50 mg
Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.
Treatment: Drugs: JNJ-70033093 100 mg
Participants will receive JNJ-70033093 100 mg (1*100 mg capsule) BID, orally for 10 to 14 postoperative days.
Treatment: Drugs: JNJ-70033093 200 mg
Participants will receive JNJ-70033093 200 mg (2*100 mg capsules) BID (in Group D) or once daily (in Group F), orally for 10 to 14 postoperative days.
Treatment: Drugs: Placebo
Participants will receive placebo matching to JNJ-70033093, orally.
Treatment: Drugs: Enoxaparin 40 mg
Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)
Query!
Assessment method [1]
0
0
Total VTE was defined as the composite of clinical events committee (CEC)-adjudicated proximal and/or distal Deep Vein Thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death.
Query!
Timepoint [1]
0
0
Up to Day 14
Query!
Secondary outcome [1]
0
0
Number of Participants With Any Bleeding Event (CEC-adjudicated)
Query!
Assessment method [1]
0
0
Any bleeding was defined as the composite of major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria modified for the surgical setting, clinically relevant nonmajor bleeding events, or minimal bleeding events as assessed by the CEC.
Query!
Timepoint [1]
0
0
Up to Day 14; Up to Day 52
Query!
Secondary outcome [2]
0
0
Number of Participants With Total VTE (CEC-adjudicated)
Query!
Assessment method [2]
0
0
Total VTE was defined as the composite of (CEC-adjudicated) proximal and/or DVT (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal PE, or any death.
Query!
Timepoint [2]
0
0
Up to Day 52
Query!
Secondary outcome [3]
0
0
Number of Participants With Composite of Major and Clinically Relevant Nonmajor Bleeding (CRNM) Events (CEC-adjudicated)
Query!
Assessment method [3]
0
0
Composite of Major bleeding event (BE): Fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; surgical site bleeding that requires second intervention open, arthroscopic, endovascular,or hemarthrosis resulting in prolonged hospitalization, deep wound infection and/or either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: Epistaxis, Gastrointestinal bleed,Hematuria,Bruising/ecchymosis,Hemoptysis,Hematoma.
Query!
Timepoint [3]
0
0
Up to Day 14, Up to Day 52
Query!
Secondary outcome [4]
0
0
Number of Participants With Major Bleeding Events (CEC-adjudicated)
Query!
Assessment method [4]
0
0
Number of participants with major BE (adjudicated by CEC) were reported. Major Bleeding events were defined as: fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.
Query!
Timepoint [4]
0
0
Up to Day 14; Up to Day 52
Query!
Secondary outcome [5]
0
0
Number of Participants With CRNM Bleeding Events (CEC-adjudicated)
Query!
Assessment method [5]
0
0
Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.
Query!
Timepoint [5]
0
0
Up to Day 14; Up to Day 52
Query!
Secondary outcome [6]
0
0
Number of Participants With Minimal Bleeding Events (CEC-adjudicated)
Query!
Assessment method [6]
0
0
Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.
Query!
Timepoint [6]
0
0
Up to Day 14; Up to Day 52
Query!
Secondary outcome [7]
0
0
Number of Participants With Major or CRNM Bleeding Events (CEC-adjudicated)
Query!
Assessment method [7]
0
0
Major Bleeding events were defined as: fatal bleeding; bleeding that is symptomatic and occurs in critical area/organ and/or; extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; either unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE is still considered clinically relevant for example: epistaxis, gastrointestinal bleed, hematuria, bruising/ecchymosis, hemoptysis, hematoma.
Query!
Timepoint [7]
0
0
Up to Day 14; Up to Day 52
Query!
Secondary outcome [8]
0
0
Number of Participants With Major VTE (CEC-adjudicated)
Query!
Assessment method [8]
0
0
Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death.
Query!
Timepoint [8]
0
0
Up to Day 52
Query!
Secondary outcome [9]
0
0
Number of Participants With Major VTE (CEC-adjudicated)
Query!
Assessment method [9]
0
0
Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death.
Query!
Timepoint [9]
0
0
Up to Day 14
Query!
Secondary outcome [10]
0
0
Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)
Query!
Assessment method [10]
0
0
Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Query!
Timepoint [10]
0
0
Up to Day 14
Query!
Secondary outcome [11]
0
0
Number of Participants With Proximal DVT (CEC-adjudicated)
Query!
Assessment method [11]
0
0
Number of participants with proximal DVT (CEC-adjudicated) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Query!
Timepoint [11]
0
0
Up to Day 52
Query!
Secondary outcome [12]
0
0
Number of Participants With Distal DVT (CEC-adjudicated)
Query!
Assessment method [12]
0
0
Number of participants with distal DVT (CEC-adjudicated) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Query!
Timepoint [12]
0
0
Up to Day 14
Query!
Secondary outcome [13]
0
0
Number of Participants With Distal DVT (CEC-adjudicated)
Query!
Assessment method [13]
0
0
Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
Query!
Timepoint [13]
0
0
Up to Day 52
Query!
Secondary outcome [14]
0
0
Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
Query!
Assessment method [14]
0
0
Number of participants with nonfatal PE (adjudicated by CEC) were reported.
Query!
Timepoint [14]
0
0
Up to Day 14
Query!
Secondary outcome [15]
0
0
Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
Query!
Assessment method [15]
0
0
Number of participants with nonfatal PE (adjudicated by CEC) were reported.
Query!
Timepoint [15]
0
0
Up to Day 52
Query!
Secondary outcome [16]
0
0
Number of Participants With Deaths (CEC-adjudicated)
Query!
Assessment method [16]
0
0
Number of participants with deaths (CEC-adjudicated) were reported.
Query!
Timepoint [16]
0
0
Up to Day 14
Query!
Secondary outcome [17]
0
0
Number of Participants With Deaths (CEC-adjudicated)
Query!
Assessment method [17]
0
0
Number of participants with deaths (CEC-adjudicated) were reported.
Query!
Timepoint [17]
0
0
Up to Day 52
Query!
Secondary outcome [18]
0
0
Apparent Clearance (CL/F) of JNJ-70033093
Query!
Assessment method [18]
0
0
Apparent clearance of a drug was defined as a measure of the rate at which a drug got metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Query!
Timepoint [18]
0
0
Up to Day 14
Query!
Secondary outcome [19]
0
0
Apparent Volume of Distribution (V/F) of JNJ-70033093
Query!
Assessment method [19]
0
0
V/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Query!
Timepoint [19]
0
0
Up to Day 14
Query!
Secondary outcome [20]
0
0
Impact of Selected Demographics: Apparent Clearance (CL/F) Based on Sex
Query!
Assessment method [20]
0
0
Impact of demographic character (sex) on CL/F was assessed.
Query!
Timepoint [20]
0
0
Up to Day 14
Query!
Secondary outcome [21]
0
0
Impact of Selected Demographic: Age on CL/F
Query!
Assessment method [21]
0
0
Impact of age on CL/F was assessed.
Query!
Timepoint [21]
0
0
Up to Day 14
Query!
Secondary outcome [22]
0
0
Impact of Selected Demographic: Weight on CL/F
Query!
Assessment method [22]
0
0
Impact of weight on CL/F was assessed.
Query!
Timepoint [22]
0
0
Up to Day 14
Query!
Secondary outcome [23]
0
0
Impact of Selected Laboratory Values: Renal Function on CL/F
Query!
Assessment method [23]
0
0
Impact of renal function on CL/F was assessed. The outcome measure was reported based on CRCL.
Query!
Timepoint [23]
0
0
Up to Day 14
Query!
Secondary outcome [24]
0
0
Impact of Selected Demographics: Sex on Apparent Volume of Distribution (V/F)
Query!
Assessment method [24]
0
0
Impact of sex on V/F was assessed.
Query!
Timepoint [24]
0
0
Up to Day 14
Query!
Secondary outcome [25]
0
0
Impact of Selected Demographics : Age on V/F
Query!
Assessment method [25]
0
0
Impact of age on V/F was assessed.
Query!
Timepoint [25]
0
0
Up to Day 14
Query!
Secondary outcome [26]
0
0
Impact of Selected Demographics : Weight on V/F
Query!
Assessment method [26]
0
0
Impact of weight on V/F was assessed.
Query!
Timepoint [26]
0
0
Up to Day 14
Query!
Secondary outcome [27]
0
0
Impact of Selected Laboratory Values: Renal Function on V/F
Query!
Assessment method [27]
0
0
Impact of renal function on V/F was assessed. The outcome measure is reported based on CRCL.
Query!
Timepoint [27]
0
0
Up to Day 14
Query!
Secondary outcome [28]
0
0
Trend Test for Primary Efficacy Event Rate (CEC Adjudicated) by Multiple Comparison Procedure - Modelling (MCP-Mod) Approach
Query!
Assessment method [28]
0
0
The dose-response trend test based on the MCP-Mod framework consisted of contrast tests defined by prespecified candidate models (4 Emax dose-response models with varying degrees of ED50). Each model was evaluated for significance of trend, based on its optimal contrast, resulting in four t-test statistics, one for each candidate model. The t-test statistics were adjusted for the fact that 4 candidate models were included in the trend testing. The dose response of the drug was then established if the maximum of the t-test statistics exceeded the 95th percentile critical value. Here 'number' signifies the estimated response rate.
Query!
Timepoint [28]
0
0
Up to 14 days
Query!
Secondary outcome [29]
0
0
Trend Test for the Composite of On-Treatment Major and Clinically Relevant Nonmajor Bleeding (CEC Adjudicated) by MCP-Mod Approach
Query!
Assessment method [29]
0
0
The dose-response trend test based on the MCP-Mod framework consisted of contrast tests defined by prespecified candidate models (4 Emax dose-response models with varying degrees of ED50). Each model was evaluated for significance of trend, based on its optimal contrast, resulting in four t-test statistics, one for each candidate model. The t-test statistics were adjusted for the fact that 4 candidate models were included in the trend testing. The dose response of the drug was then established if the maximum of the t-test statistics exceeded the 95th percentile critical value. Here 'number' signifies the estimated response rate.
Query!
Timepoint [29]
0
0
Up to 14 days
Query!
Eligibility
Key inclusion criteria
- Medically stable and appropriate for anticoagulant prophylaxis as determined by the
investigator on the basis of physical examination, medical history, and vital signs
performed as part of screening for elective total knee replacement (TKR) surgery
- Medically stable and appropriate for anticoagulant prophylaxis on the basis of
clinical laboratory tests performed as part of local standard-of-care as part of
screening for elective TKR surgery
- Has plans to undergo an elective primary unilateral TKR surgery
- A woman must be- a) Not of childbearing potential; b) Of childbearing potential and
practicing a highly effective method of contraception (failure rate of less than [<]1
percent [%] per year when used consistently and correctly) and agrees to remain on a
highly effective method for the duration of study drug with JNJ-70033093 plus 5
half-lives of study drug plus 30 days (duration of ovulatory cycle) for a total of 34
days after the completion of treatment, pregnancy testing (serum or urine) prior to
the first dose of study drug
- Willing and able to adhere to the lifestyle restrictions specified in this protocol
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- History of any condition for which the use of low molecular-weight heparin (LMWH) is
not recommended in the opinion of the investigator (for example, previous allergic
reaction, creatinine clearance <30 milliliter per minute [mL/minute])
- History of severe hepatic impairment
- Planned bilateral revision or unicompartmental procedure
- Unable to undergo venography (for example, due to contrast agent allergy, poor venous
access, or impaired renal function that would increase the risk of contrast-induced
nephropathy
- Known previous pulmonary embolism (PE) or deep vein thrombosis (DVT) in either lower
extremity
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
17/06/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
6/04/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1242
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
Argentina
Query!
State/province [8]
0
0
Caba
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Ciudad Autonoma de Buenos Aires
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Córdoba
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
La Plata
Query!
Country [12]
0
0
Argentina
Query!
State/province [12]
0
0
Rosario
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
San Martín
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Antwerpen
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Genk
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Hasselt
Query!
Country [17]
0
0
Belgium
Query!
State/province [17]
0
0
Merksem
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Belo Horizonte
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Santo André
Query!
Country [20]
0
0
Bulgaria
Query!
State/province [20]
0
0
Pleven
Query!
Country [21]
0
0
Bulgaria
Query!
State/province [21]
0
0
Sofa
Query!
Country [22]
0
0
Bulgaria
Query!
State/province [22]
0
0
Sofia
Query!
Country [23]
0
0
Bulgaria
Query!
State/province [23]
0
0
Stara Zagora
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Ontario
Query!
Country [25]
0
0
Greece
Query!
State/province [25]
0
0
Kifisia
Query!
Country [26]
0
0
Greece
Query!
State/province [26]
0
0
Nea Ionia
Query!
Country [27]
0
0
Greece
Query!
State/province [27]
0
0
Patra
Query!
Country [28]
0
0
Greece
Query!
State/province [28]
0
0
Thessaloniki
Query!
Country [29]
0
0
Hungary
Query!
State/province [29]
0
0
Budapest
Query!
Country [30]
0
0
Hungary
Query!
State/province [30]
0
0
Debrecen
Query!
Country [31]
0
0
Hungary
Query!
State/province [31]
0
0
Gyõr
Query!
Country [32]
0
0
Hungary
Query!
State/province [32]
0
0
Kaposvar
Query!
Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Kecskemét
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Szeged
Query!
Country [35]
0
0
Hungary
Query!
State/province [35]
0
0
Szekesfehervar
Query!
Country [36]
0
0
Hungary
Query!
State/province [36]
0
0
Szolnok
Query!
Country [37]
0
0
Israel
Query!
State/province [37]
0
0
Haifa
Query!
Country [38]
0
0
Israel
Query!
State/province [38]
0
0
Kfar Saba
Query!
Country [39]
0
0
Israel
Query!
State/province [39]
0
0
Rehovot
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Bergamo
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Bologna
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Pavia
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Rozzano
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Torino
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Chiba
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Hakodate
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Hamamatsu
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Itami-shi
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Kagoshima-shi
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Kitakyushu-shi,
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Matsumoto
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Nagoya
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Nerima-Ku
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Okayama
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Okinawa, Tomigusuku-shi
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Saitama-shi
Query!
Country [57]
0
0
Japan
Query!
State/province [57]
0
0
Saitama
Query!
Country [58]
0
0
Japan
Query!
State/province [58]
0
0
Suzaka
Query!
Country [59]
0
0
Japan
Query!
State/province [59]
0
0
Tokyo
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Bielsk Podlaski
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Grajewo
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Kielce
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Krakow
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Lodz
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Lublin
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Tarnow
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Warszawa
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Wroclaw
Query!
Country [69]
0
0
Portugal
Query!
State/province [69]
0
0
Aveiro
Query!
Country [70]
0
0
Portugal
Query!
State/province [70]
0
0
Cascais
Query!
Country [71]
0
0
Portugal
Query!
State/province [71]
0
0
Porto
Query!
Country [72]
0
0
Portugal
Query!
State/province [72]
0
0
Setubal
Query!
Country [73]
0
0
Portugal
Query!
State/province [73]
0
0
Viana do Castelo
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
Kurgan
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
Moscow
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Nizhniy Novgorod
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Saint-Petersburg
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Samara
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Smolensk
Query!
Country [80]
0
0
Russian Federation
Query!
State/province [80]
0
0
Sochi
Query!
Country [81]
0
0
South Africa
Query!
State/province [81]
0
0
Pretoria
Query!
Country [82]
0
0
South Africa
Query!
State/province [82]
0
0
Worcester
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Alcorcón
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Badalona
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Barcelona
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Jaen
Query!
Country [87]
0
0
Spain
Query!
State/province [87]
0
0
Madrid
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Sabadell
Query!
Country [89]
0
0
Spain
Query!
State/province [89]
0
0
Valencia
Query!
Country [90]
0
0
Turkey
Query!
State/province [90]
0
0
Adana
Query!
Country [91]
0
0
Turkey
Query!
State/province [91]
0
0
Ankara
Query!
Country [92]
0
0
Turkey
Query!
State/province [92]
0
0
Antalya
Query!
Country [93]
0
0
Turkey
Query!
State/province [93]
0
0
Istanbul
Query!
Country [94]
0
0
Turkey
Query!
State/province [94]
0
0
Izmir
Query!
Country [95]
0
0
Ukraine
Query!
State/province [95]
0
0
Ivano-Frankivsk
Query!
Country [96]
0
0
Ukraine
Query!
State/province [96]
0
0
Kharkiv
Query!
Country [97]
0
0
Ukraine
Query!
State/province [97]
0
0
Kyiv
Query!
Country [98]
0
0
Ukraine
Query!
State/province [98]
0
0
Lviv-Vynnyky
Query!
Country [99]
0
0
Ukraine
Query!
State/province [99]
0
0
Odesa
Query!
Country [100]
0
0
Ukraine
Query!
State/province [100]
0
0
Vinnytsia
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Bristol-Myers Squibb
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to determine the efficacy of JNJ-70033093 in preventing total
venous thromboembolism (VTE) events (proximal and/or distal deep vein thrombosis [DVT]
[asymptomatic confirmed by venography assessment or objectively confirmed symptomatic],
nonfatal pulmonary embolism [PE], or any death) during the treatment period.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03891524
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03891524
Download to PDF