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NCT03251482 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 308
- Enrollment target
NCT03251482 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 308 participants.
The verdict
NCT03251482, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 308 participants
- Enrollment target
Study Summary
The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (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).
Interventions
- DRUG JNJ-64179375 0.3 mg/kg
- DRUG JNJ-64179375 0.6 mg/kg
- DRUG JNJ-64179375 1.2 mg/kg
- DRUG JNJ-64179375 (Dose to be Determined)
- DRUG JNJ-64179375 A mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2017-11-13 |
| Est. Completion | 2018-11-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03251482
The ClinicalTrials.gov registry entry for NCT03251482 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which JNJ-64179375 0.3 mg/kg is the first listed.
NCT03251482 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03251482 about?
NCT03251482 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery". The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary...
What is the current status of trial NCT03251482?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 308 participants. The study started on 2017-11-13. Estimated completion is 2018-11-05.
What interventions are being tested in trial NCT03251482?
The interventions under investigation include: JNJ-64179375 0.3 mg/kg (DRUG), JNJ-64179375 0.6 mg/kg (DRUG), JNJ-64179375 1.2 mg/kg (DRUG), JNJ-64179375 (Dose to be Determined) (DRUG), JNJ-64179375 A mg/kg (DRUG).
Who is sponsoring clinical trial NCT03251482?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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