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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: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT03251482 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 308 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.
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 |
What the finished NCT03251482 record still lists
NCT03251482 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (132% higher).
The record links to 0 conditions, and to 5 interventions - of which JNJ-64179375 0.3 mg/kg is the first listed.
NCT03251482 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03251482's enrollment target sits among peer trials
308 163rd of 2000 higher than 1,836 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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