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

NCT03891524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1242

Last updated 2025-03-30

Study results available
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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.

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.

Sponsors & Collaborators

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2021-04-06
Completion
2021-04-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Poland
  • Portugal
  • Russia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03891524 on ClinicalTrials.gov