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NCT02555878 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 841
- Enrollment target
NCT02555878: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02555878 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 841 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02555878, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 841 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.
Primary Outcome
Percentage of participants with time to the first occurrence of primary efficacy endpoint (composite and components) was reported. The primary efficacy composite endpoint is time to first occurrence of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, or VTE-related death as adjudicated by an independent blinded Clinical Endpoint Committee (CEC).
Interventions
- DRUG Placebo
- DRUG Rivaroxaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 841 participants |
| Start Date | 2015-09-11 |
| Est. Completion | 2018-08-24 |
| Phase | Phase 3 |
What the finished NCT02555878 record still lists
NCT02555878 is an interventional study that assigns participants to a tested intervention. The registered 841 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02555878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02555878 about?
NCT02555878 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants". The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower...
What is the current status of trial NCT02555878?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 841 participants. The study started on 2015-09-11. Estimated completion is 2018-08-24.
What interventions are being tested in trial NCT02555878?
The interventions under investigation include: Placebo (DRUG), Rivaroxaban (DRUG).
Who is sponsoring clinical trial NCT02555878?
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 NCT02555878's enrollment target sits among peer trials
841 392nd of 2000 higher than 1,609 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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