A Study of JNJ-70033093 (BMS-986177) Versus Subcutaneous Enoxaparin in Participants Undergoing Elective Total Knee Replacement Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

1,242

Participants

Timeline

Start Date

June 17, 2019

Primary Completion Date

April 6, 2021

Study Completion Date

April 6, 2021

Conditions
Arthroplasty, Replacement, Knee
Interventions
DRUG

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.

DRUG

JNJ-70033093 50 mg

Participants will receive JNJ-70033093 50 mg (2\*25 mg capsules) BID orally for 10 to 14 postoperative days.

DRUG

JNJ-70033093 100 mg

Participants will receive JNJ-70033093 100 mg (1\*100 mg capsule) BID, orally for 10 to 14 postoperative days.

DRUG

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.

DRUG

Placebo

Participants will receive placebo matching to JNJ-70033093, orally.

DRUG

Enoxaparin 40 mg

Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.

Trial Locations (117)

1085

Semmelweis Egyetem, Budapest

1330

University Multiprofile Hospital Sofiamed Sofia, Sofia

1407

Acibadem City Clinic Tokuda Hospital, Sofa

1527

MHAT Tzaritza Joanna, Sofia

2020

ZNA Middelheim, Antwerp

2170

ZNA Jan Palfijn, Merksem

3500

Jessa Ziekenhuis, Hasselt

3600

Ziekenhuis Oost-Limburg, Genk

4032

Debreceni Egyetem, Debrecen

5000

Hospital San Roque, Córdoba

MAV Korhaz es Rendelointezet, Szolnok

5800

University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven

6000

Medical Center - Medical Complex BEROE EOOD, Stara Zagora

Bacs-kiskun Megyei Korhaz, Kecskemét

6725

Szegedi Tudomanyegyetem, Szeged

6850

Clinical Project Research SA, Worcester

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár

8000

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz, Székesfehérvár

8035

Hosp Univ Vall D Hebron, Barcelona

9023

Petz Aladar Megyei Oktato Korhaz, Gyõr

10126

A.O.U. Città della Salute e della Scienza, Torino

14233

General Hospital of Nea Ionia 'Konstantopoulio', Nea Ionia

14561

General Hospital of Attiki 'KAT', Kifissia

20089

Istituto Clinico Humanitas, Rozzano

21018

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov, Vinnytsia

23007

Complejo Hospitalario de Jaen, Jaén

24125

Cliniche Humanitas Gavazzeni, Bergamo

24127

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

26504

University General Hospital of Rio Patras, Pátrai

27100

Policlinico S. Matteo, Pavia

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. La Paz, Madrid

28922

Hosp. Univ. Fundacion Alcorcon, Alcorcón

31096

Rambam Medical Center, Haifa

33321

University Orthopedic and Joint Replacement Center, Tamarac

33782

DMI Research, Pinellas Park

34147

Bakirkoy Training and Research Hospital, Istanbul

34232

Gulfcoast Research Institute, Sarasota

34362

Carmel Medical Center, Haifa

34371

Sisli Etfal Research Training Hospital, Istanbul

35180

Izmir Tepecik Training and Research Hospital, Izmir

35205

Central Research Associates, Inc., Birmingham

40136

Istituto Ortopedico Rizzoli, Bologna

44281

Meir Medical Center, Kfar Saba

46010

Hosp. Clinico Univ. de Valencia, Valencia

46026

Hosp. Univ. I Politecni La Fe, Valencia

56403

Papageorgiou General Hospital, Thessaloniki

61024

Institute of Spine and JointPathology named after Prof.Sytenko of NationalAcademy of MedicalSciences, Kharkiv

61176

Municipal Institution of Health Care 'Kharkiv Regional Clinical Traumatology Hospital', Kharkiv

65025

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council, Odesa

72205

Bowen Hefley Orthopedics, Little Rock

76008

Ivano-Frankivsk Regional Clinical Hospital, Ivano-Frankivsk

77024

Memorial Hermann Memorial City Medical Center, Houston

79495

Communal Institution of Lviv Regional Council 'Lypa Lviv Regional Hospital', Lviv-Vynnyky

80113

Denver Metro Orthopedics, PC, Englewood

85053

Arizona Research Center, Phoenix

90502

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

109386

Private Healthcare Institution 'Clinical Hospital 'RZD-Medcine' n.a. N.A.Semashko', Moscow

195427

National medical research center of Traumatology and Orthopaedics n.a. R.R.Vreden, Saint Petersburg

214031

Smolensk Federal Center of Traumatology, Orthopedics and Endoprothesis Replacement, Smolensk

354057

Sochi City Hospital #4, Sochi

443095

State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin, Samara

603137

Privolzhsky Regional Medical Center of Federal Medical and Biological Agency, Nizhny Novgorod

640014

National Medical Research Center of Traumatology and Orthopaedics n.a. G.A. Ilizarov, Kurgan

7610001

Kaplan Medical Center, Rehovot

C1280AEB

Hospital Britanico de Buenos Aires, Buenos Aires

C1430EGF

Clinica Adventista Belgrano, CABA

X5000EPU

Clínica Chutro, Córdoba

B1900AXI

Hospital Italiano La Plata, La Plata

S2000BIF

Instituto de Investigaciones Clinicas Rosario, Rosario

B1650BNB

Sanatorio Corporación Médica de General San Martín, San Martín

30360-290

Hospital Sao Francisco de Assis, Belo Horizonte

09030-010

Hospital e Maternidade Dr Christovao da Gama S.A, Santo André

09190-615

Hospital Estadual Mario covas, Santo André

L1S 2J4

Lakeridge Health, Ajax

L8V1C3

Hamilton Health Sciences Corporation, Hamilton

K1H 8L6

The Ottawa Hospital Research Institute, Ottawa

N8W 1E6

Medical Investigative and Clinical Evaluation Inc, Windsor

270-2296

Matsudo City General Hospital, Chiba

040 8611

Hakodate Goryoukaku Hospital, Hakodate

434-8533

Japanese Red Cross Hamamatsu Hospital, Hamamatsu

664-8540

Itami City Hospital, Itami-shi

890-0062

Yonemori Hospital, Kagoshima

806-8501

Japan Community Health care Organization Kyushu Hospital, Kitakyushu-shi

390-8601

Marunouchi Hospital, Matsumoto

455-8530

Chubu Rosai Hospital, Nagoya

177-8521

Juntendo University Nerima Hospital, Nerima-Ku

701-1192

National Hospital Organization Okayama Medical Center, Okayama

901-0224

Yuuai Medical Center, Okinawa

350-8550

Japan Community Health Care Organization Saitama Medical Center, Saitama

336-8522

Saitama City Hospital, Saitama-shi

386-8610

Nagano Prefectural Shinshu Medical Center, Suzaka

113-8431

Juntendo University Hospital, Tokyo

17 100

Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bielsku Podlaskim Oddzial Urazowo Ortopedyczny, Bielsk Podlaski

19-200

Szpital Ogolny im. W. Ginela, Oddzial Urazowo-Ortopedyczny, Grajewo

25-001

Wojewodzki Szpital Zespolony w Kielcach, Klinika Chirurgii Ortopedyczno-Urazowej, Kielce

31 826

Oddzial Ortopedii i Traumatologii Narzadu Ruchu Szpital Specjalistyczny im Ludwika Rydygiera, Krakow

92-213

CSK UM Klinika Ortopedii, Lodz

20-718

Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny, Lublin

33-100

Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika, Tarnów

03 242

Oddzial Chirurgii Urazowej iOrtopedycznej Wojewodzki Szpital Brodnowski SPZOZ, Warsaw

50 556

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

3810-501

Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro, Aveiro

2755-009

Hosp de Cascais, Cascais

4099-001

H. Santo António - Centro Hospitalar do Porto, Porto

2900-180

CHS - Hosp. Orto. Sant'Iago do Outao, Setúbal

4904-858

ULSAM, EPE - Hospital de Santa Luzia, Viana do Castelo

0001

Steve Biko Academic Hospital, Pretoria

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

08036

Hosp Clinic de Barcelona, Barcelona

08907

Hosp. Univ. de Bellvitge, Barcelona

08208

Corporacio Sanitari Parc Tauli, Sabadell

01060

Adana City Hospital, Adana

06110

Diskapi Yildırim Beyazid Training and Research Hospital, Ankara

06370

Yıldırım Beyazıt University Yenimahalle Training and Research Hospital, Ankara

07100

Antalya Training And Research Hospital, Antalya

04107

Kyiv Regional Clinical Hospital, Kyiv

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY