| Trial ID: | L5444 |
| Source ID: | NCT04881799
|
| Associated Drug: |
Phentermine/Topiramate (Qsymia)
|
| Title: |
Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Pediatric Obesity
|
| Interventions: |
DRUG: Phentermine/Topiramate (Qsymia)|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in body mass index, The percent change in body mass index (BMI) from Baseline to Month 6 will be calculated. BMI is defined as a person's weight in kilograms divided by the square of height in meters., 6 Months |
|
| Sponsor/Collaborators: |
Sponsor: University of Minnesota
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-07-07
|
| Completion Date: |
2025-08-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-08
|
| Locations: |
University of Minnesota, Minneapolis, Minnesota, 55414, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04881799
|
