Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00097357




Registration number
NCT00097357
Ethics application status
Date submitted
22/11/2004
Date registered
23/11/2004
Date last updated
2/03/2010

Titles & IDs
Public title
BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
Scientific title
A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
Secondary ID [1] 0 0
CV185-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - Enoxaparin
Treatment: Drugs - Warfarin
Treatment: Drugs - Enoxaparin Placebo
Treatment: Drugs - Apixaban Placebo

Experimental: A1 - Apixaban: 2.5 mg, BID

PLUS

Enoxaparin Placebo

Experimental: A2 - Apixaban: 5 mg, BID

PLUS

Enoxaparin Placebo

Experimental: A3 - Apixaban: 10 mg, BID

PLUS

Enoxaparin Placebo

Experimental: A4 - Apixaban: 5 mg, QD

PLUS

Enoxaparin Placebo

Experimental: A5 - Apixaban: 10 mg, QD

PLUS

Enoxaparin Placebo

Experimental: A6 - Apixaban: 20 mg, QD

PLUS

Enoxaparin Placebo

Active comparator: E1 - Enoxaparin: 30 mg

PLUS

Apixaban Placebo

Active comparator: W1 - Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0


Treatment: Drugs: Apixaban
Tablets, Oral, 12 +/- 2 days

Treatment: Drugs: Enoxaparin
Injection, SQ, Q12H, 12 +/- 2 days

Treatment: Drugs: Warfarin
Tablets, Oral, QD, 12 +/- 2 days

Treatment: Drugs: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days

Treatment: Drugs: Apixaban Placebo
Tablets, Oral, BID, 12 +/- 2 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine the dose-response relationship among the 3 QD and 3 BID doses of BMS-562247 on the composite endpoint of adjudicated VTE events and all-cause death in subjects treated with study medication for 12 +/-2 days following surgery
Timepoint [1] 0 0
throughout the study
Secondary outcome [1] 0 0
Assess the effect of QD and BID dose of BMS-562247 vs subcutaneous 30 mg q12h enoxaparin and warfarin on the composite endpoint of adjudication VTE events and all-cause death in subjects treated for 12 +/-2 days following surgery
Timepoint [1] 0 0
throughout the study
Secondary outcome [2] 0 0
Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated major bleeding events in subjects treated with study medication for 12 +/-2 days following surgery
Timepoint [2] 0 0
throughout the study
Secondary outcome [3] 0 0
Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated minor bleeding events in subjects treated with study medication for 12 +/-2 days following surgery
Timepoint [3] 0 0
throughout the study
Secondary outcome [4] 0 0
To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule
Timepoint [4] 0 0
throughout the study

Eligibility
Key inclusion criteria
* Undergoing elective unilateral total knee replacement surgery.
* Willing and able to undergo bilateral ascending contrast venography.
* Able to inject (by self or caregiver) study medication subcutaneously.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women of childbearing potential.
* Women who are pregnant or breastfeeding.
* Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) >=35 kg/m2

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
1238
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Chermside
Recruitment hospital [3] 0 0
Local Institution - Gold Coast
Recruitment hospital [4] 0 0
Local Institution - Herston
Recruitment hospital [5] 0 0
Local Institution - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - Box Hill
Recruitment hospital [7] 0 0
Local Institution - Clayton
Recruitment hospital [8] 0 0
Local Institution - East Ringwood
Recruitment hospital [9] 0 0
Local Institution - Geelong
Recruitment hospital [10] 0 0
Local Institution - Windsor
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Chermside
Recruitment postcode(s) [3] 0 0
- Gold Coast
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Bedford Park
Recruitment postcode(s) [6] 0 0
- Box Hill
Recruitment postcode(s) [7] 0 0
- Clayton
Recruitment postcode(s) [8] 0 0
- East Ringwood
Recruitment postcode(s) [9] 0 0
- Geelong
Recruitment postcode(s) [10] 0 0
- Windsor
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Mendoza
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Nova Scotia
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Denmark
State/province [35] 0 0
Frederiksberg
Country [36] 0 0
Denmark
State/province [36] 0 0
Herlev
Country [37] 0 0
Denmark
State/province [37] 0 0
Horsholm
Country [38] 0 0
Denmark
State/province [38] 0 0
Silkeborg
Country [39] 0 0
Denmark
State/province [39] 0 0
Slagelse
Country [40] 0 0
Israel
State/province [40] 0 0
Haifa
Country [41] 0 0
Israel
State/province [41] 0 0
Holon
Country [42] 0 0
Israel
State/province [42] 0 0
Kfar Saba
Country [43] 0 0
Israel
State/province [43] 0 0
Petach-tikva
Country [44] 0 0
Israel
State/province [44] 0 0
Ramat Gan
Country [45] 0 0
Israel
State/province [45] 0 0
Rehovot
Country [46] 0 0
Israel
State/province [46] 0 0
Tel Aviv
Country [47] 0 0
Israel
State/province [47] 0 0
Zerifin
Country [48] 0 0
Mexico
State/province [48] 0 0
Baja California Sur
Country [49] 0 0
Mexico
State/province [49] 0 0
Distrito Federal
Country [50] 0 0
Mexico
State/province [50] 0 0
Estado De Mexico
Country [51] 0 0
Mexico
State/province [51] 0 0
Jalisco
Country [52] 0 0
Mexico
State/province [52] 0 0
Nuevo Leon
Country [53] 0 0
Mexico
State/province [53] 0 0
Sinaloa
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Mexico
State/province [54] 0 0
Sonora
Country [55] 0 0
Mexico
State/province [55] 0 0
Tamaulipas
Country [56] 0 0
Mexico
State/province [56] 0 0
Veracruz
Country [57] 0 0
Mexico
State/province [57] 0 0
Yucatan
Country [58] 0 0
Mexico
State/province [58] 0 0
Aguascalientes
Country [59] 0 0
Mexico
State/province [59] 0 0
Chihuahua
Country [60] 0 0
Poland
State/province [60] 0 0
Bialystock
Country [61] 0 0
Poland
State/province [61] 0 0
Gdansk
Country [62] 0 0
Poland
State/province [62] 0 0
Lodz
Country [63] 0 0
Poland
State/province [63] 0 0
Lublin
Country [64] 0 0
Poland
State/province [64] 0 0
Piekary Slaskie
Country [65] 0 0
Poland
State/province [65] 0 0
Radom
Country [66] 0 0
Poland
State/province [66] 0 0
Sosnowiec
Country [67] 0 0
Poland
State/province [67] 0 0
Szczecin Zdunowo
Country [68] 0 0
Poland
State/province [68] 0 0
Szczecin
Country [69] 0 0
Poland
State/province [69] 0 0
Warszawa
Country [70] 0 0
Puerto Rico
State/province [70] 0 0
Ponce

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00097357