Conditions: Pediatric Obesity Childhood Obesity
Keywords: Adolescent Obesity Childhood Obesity Qsymia Pharmacokinetics VI-0521 Phentermine Topiramate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 42
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Days 1-56: Placebo arm 2: * Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg) arm 3: * Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)

Interventions: intervention 1: Placebo intervention 2: VI-0521 Mid Dose intervention 3: VI-0521 Top Dose
Intervention descriptions: intervention 1: po once daily intervention 2: po once daily intervention 3: po once daily

Protocol document: