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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. 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).
Interventions
- DRUG Apixaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-07-19 |
| Est. Completion | 2020-02-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02406885
The ClinicalTrials.gov registry entry for NCT02406885 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Apixaban is the first listed.
NCT02406885 reports 0 study locations.
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.
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