Pharmacotherapy for Pediatric Obesity: A Phentermine Clinical Trial
NCT04678323 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2021-08-05
Summary
This is a multi-site, randomized, placebo-controlled clinical trial to examine the weight loss efficacy and cardiovascular safety of phentermine 15 mg daily plus lifestyle therapy versus placebo plus lifestyle therapy among 200 adolescents ages ≥10 to \<18 years with obesity.
Conditions
- Obesity, Childhood
Interventions
- DRUG
-
Lifestyle Management
Participants in this group will receive lifestyle management.
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-31
- Primary Completion
- 2027-12-31
- Completion
- 2028-06-30
- FDA Drug
- Yes
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