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NCT02406885 · ClinicalTrials.gov registry record · Phase 4
Apixaban Pharmacokinetics in Bariatric Patients (APB)
A Phase 4 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT02406885: Completed Phase 4 study, sponsored by Johns Hopkins University.
NCT02406885 is a Phase 4 study that has completed, run by Johns Hopkins University. The registered enrollment target is 33 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02406885, a Phase 4 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study Summary
The Center for Bariatric Surgery is interested in conducting a pharmacokinetic study of apixaban (an oral anticoagulant with FDA approval for use of venous thrombo embolism (VTE) prophylaxis and treatment) in the obese adult population to determine if bariatric surgery influences apixaban exposure. More interesting would be to see how the dose may need to change pre- vs. post-bariatric surgery (this will be important for physicians as more and more patients undergo this procedure worldwide and many may require anticoagulation in their future healthcare). Physicians and surgeons are very interested in oral anticoagulants for this special patient population. To date, there is no approved dosing for the obese patient (especially when considering surgical intervention such as bariatric surgery). Primary outcome variable. To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index (BMI) of 35 kg/m2 or greater following one of two bariatric surgical procedures (pre-operative versus post-operative vertical sleeve gastrectomy or Roux-en-Y gastric bypass patients). Secondary outcome variables. 1. To compare/contrast the pharmacokinetics and pharmacodynamics of apixaban in bariatric surgical patients who have undergone RYGB vs. VSG. 2. To determine how the pharmacokinetics of the drug may differ when there is significant post-operative surgical weight loss (\>40% estimated excess body weight) 12 to 18 months following surgery versus those patients who have suboptimal weight loss following bariatric surgery (\< 40% of estimated excess body weight).
Primary Outcome
To determine the durability or change in pharmacokinetics of apixaban in patients with obesity following one of two bariatric surgical procedures. Change in Cmax (ng/ml) between 12 months and baseline.
Interventions
- DRUG Apixaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-07-19 |
| Est. Completion | 2020-02-01 |
| Phase | Phase 4 |
What the finished NCT02406885 record still lists
NCT02406885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Apixaban is the first listed.
NCT02406885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02406885 about?
NCT02406885 is a clinical study titled "Apixaban Pharmacokinetics in Bariatric Patients (APB)". The Center for Bariatric Surgery is interested in conducting a pharmacokinetic study of apixaban (an oral anticoagulant with FDA approval for use of venous thrombo embolism (VTE) prophylaxis and treatment) in the obese adult population to determine if bariatric surgery influences apixaban exposure. ...
What is the current status of trial NCT02406885?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2017-07-19. Estimated completion is 2020-02-01.
What interventions are being tested in trial NCT02406885?
The interventions under investigation include: Apixaban (DRUG).
Who is sponsoring clinical trial NCT02406885?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02406885's enrollment target sits among peer trials
33 1528th of 2000 higher than 467 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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