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A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents

NCT02714062 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-08-23

Study results available
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Summary

The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.

Conditions

  • Pediatric Obesity
  • Childhood Obesity

Interventions

DRUG

Placebo

po once daily

DRUG

VI-0521 Mid Dose

po once daily

DRUG

VI-0521 Top Dose

po once daily

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Daniel Hsia, M.D. · Pennington Biomedical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-10-31
Completion
2016-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02714062 on ClinicalTrials.gov