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NCT02229214 · ClinicalTrials.gov registry record · Phase 4
Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects
A Phase 4 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT02229214: Completed Phase 4 study, sponsored by VIVUS.
NCT02229214 is a Phase 4 study that has completed, run by VIVUS. The registered enrollment target is 51 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02229214, a Phase 4 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of off-treatment recovery.
Primary Outcome
Method that uses iohexol clearance and body surface area to measure kidney function. Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR.
Interventions
- DRUG Placebo
- DRUG Qsymia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
What the finished NCT02229214 record still lists
NCT02229214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02229214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02229214 about?
NCT02229214 is a clinical study titled "Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects". The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of off-treatment recovery.
What is the current status of trial NCT02229214?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2014-08. Estimated completion is 2014-11.
What interventions are being tested in trial NCT02229214?
The interventions under investigation include: Placebo (DRUG), Qsymia (DRUG).
Who is sponsoring clinical trial NCT02229214?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02229214's enrollment target sits among peer trials
51 1249th of 2000 higher than 746 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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