Status:
WITHDRAWN
Pharmacotherapy for Pediatric Obesity: A Phentermine Clinical Trial
Lead Sponsor:
University of Minnesota
Conditions:
Obesity, Childhood
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Obesity in children and adolescents (body mass index \[BMI\] ≥95th percentile) is a chronic, progressive, and debilitating disease with a prevalence of \>20% in the U.S.1 Cardiovascular (CV) complicat...
Eligibility Criteria
Inclusion
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 10-\<18 years
- BMI ≥ 95th age- and sex-specific Centers for Disease Control (CDC) percentile
- Tanner stage ≥ 1
- Ability to take oral medication and be willing to adhere to the lifestyle therapy regimen
Exclusion
- Contraindications to phentermine including: history of cardiovascular disease (including coronary artery disease, stroke, clinically significant congenital heart disease, clinically significant cardiac arrhythmias, congestive heart failure); glaucoma; current or recent (\<14 days) use of MAO inhibitors; history of or current chemical dependency; current pregnancy or plans to be pregnant during course of study or lactation; known hypersensitivity to sympathomimetic amines.
- Hypertension
- Cardiac pacemaker
- Type 1 or type 2 diabetes mellitus
- Current or recent (\<6 months prior to enrollment) use of weight loss medication(s)
- Current use of other sympathomimetic amines such as ADHD stimulants
- History of bariatric surgery
- Schizophrenia, psychosis, or mania
- Any history of suicide attempt
- Self-harm within 12 months prior to screening
- PHQ-9 score of ≥15 at screening
- Suicidal ideation of type 4 or 5 on C-SSRS in past month
- Hyperthyroidism
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04678323
Start Date
January 1 2022
End Date
June 1 2028
Last Update
August 5 2021
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