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NCT02058199 · ClinicalTrials.gov registry record · Phase 1
Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery
A Phase 1 study, sponsored by State University of New York - Upstate Medical University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02058199 is a Phase 1 study that was terminated before completion, run by State University of New York - Upstate Medical University. The registered enrollment target is 2 participants.
The verdict
NCT02058199, a Phase 1 study, was terminated before completion, sponsored by State University of New York - Upstate Medical University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The investigators are attempting to compare the anticoagulant (blood thinning) effects of a recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass surgery to people who have not had this surgery. It is thought that gastric bypass may alter the absorption of this medication, but this has not been previously studied. The investigators will study the anticoagulant effect of rivaroxaban in healthy volunteers who are in one of four groups 1. Non obese people who have not had a gastric bypass. 2. Obese people who have not had a gastric bypass 3. People who have had a gastric bypass 4. People who are planning to undergo gastric bypass surgery in the near future who are willing to be studied before and after the bypass. The study will involve taking a single low dose of rivaroxaban and multiple blood samples will be taken over the next 24 hours and the effect of rivaroxaban on blood clotting will be measured using the prothrombin time and an anti-factor Xa assay. The effects of rivaroxaban will be compared between the different groups.
Interventions
- DRUG rivaroxaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-12 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02058199
The ClinicalTrials.gov registry entry for NCT02058199 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Upstate Medical University, which has 113 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rivaroxaban is the first listed.
NCT02058199 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02058199 about?
NCT02058199 is a clinical study titled "Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery". The investigators are attempting to compare the anticoagulant (blood thinning) effects of a recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass surgery to people who have not had this surgery. It is thought that gastric bypass may alter the absorption of this m...
What is the current status of trial NCT02058199?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2014-12. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02058199?
The interventions under investigation include: rivaroxaban (DRUG).
Who is sponsoring clinical trial NCT02058199?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
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