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NCT03922945 · ClinicalTrials.gov registry record · Phase 4
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
A Phase 4 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 4
- Development phase
- 223
- Enrollment target
NCT03922945 is a Phase 4 study that has completed, run by VIVUS. The registered enrollment target is 223 participants.
The verdict
NCT03922945, a Phase 4 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 223 participants
- Enrollment target
Study Summary
This study is being conducted to assess weight loss efficacy, as determined by changes in body mass index (BMI), and safety of VI-0521 (Qsymia®) or placebo, taken for 56 weeks accompanied by a lifestyle modification program in obese adolescents age 12-16 years.
Interventions
- DRUG Placebo oral capsule
- BEHAVIORAL Lifestyle Modification
- DRUG VI-0521 oral capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2019-05-02 |
| Est. Completion | 2021-04-16 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03922945
The ClinicalTrials.gov registry entry for NCT03922945 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 223 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VIVUS, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo oral capsule is the first listed.
NCT03922945 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03922945 about?
NCT03922945 is a clinical study titled "A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity". This study is being conducted to assess weight loss efficacy, as determined by changes in body mass index (BMI), and safety of VI-0521 (Qsymia®) or placebo, taken for 56 weeks accompanied by a lifestyle modification program in obese adolescents age 12-16 years.
What is the current status of trial NCT03922945?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 223 participants. The study started on 2019-05-02. Estimated completion is 2021-04-16.
What interventions are being tested in trial NCT03922945?
The interventions under investigation include: Placebo oral capsule (DRUG), Lifestyle Modification (BEHAVIORAL), VI-0521 oral capsule (DRUG).
Who is sponsoring clinical trial NCT03922945?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
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