Trial · NCT04095104
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Enrollment Rate | 6 months | (Number enrolled divided by number eligible) x 100 |
| Primary | Dropout Rate | 24 months | Number who do not complete the study divided by number enrolled |
| Primary | Number of Participants Adherent to Study Drugs | 12 weeks | Presence of amphetamine in the urine at any study visit |
| Primary | Frequency of Adverse Events | 24 months | Unique adverse events documented prior to unblinding. Adverse events were elicited using a standardized checklist during study phone calls and in-person study visits, laboratory monitoring, review of systems, vitals, physical exam, and mood/suicidality assessment using validated instruments at every study visit. |
| Secondary | Percent BMI Change | Baseline and 12 weeks | (Baseline BMI - BMI at 12 weeks)/Baseline BMI x 100 |
| Secondary | Percent Weight Change | Baseline and 12 weeks | (Baseline weight - weight at 12 weeks)/Baseline weight x 100 |
| Secondary | Change in BMI Percent of the 95th%Ile | Baseline and 12 weeks | (Baseline BMI % of the 95th%ile - BMI % of the 95th%ile at 12 weeks) |
| Secondary | Change in Heart Rate | Baseline and 12 weeks | (Heart rate at baseline - Heart rate at 12 weeks) |
| Secondary | Change in Systolic Blood Pressure | Baseline and 12 weeks | Systolic blood pressure at baseline - Systolic blood pressure at 12 weeks |
| Secondary | Change in Diastolic Blood Pressure | Baseline and 12 weeks | Diastolic blood pressure at baseline - Diastolic blood pressure at 12 weeks |
| Secondary | Change in Total Cholesterol (mg/dL) | Baseline and 12 weeks | Total cholesterol at baseline - Total cholesterol at 12 weeks |
| Secondary | Change in Triglycerides (mg/dL) | Baseline and 12 weeks | Triglycerides at baseline - Triglycerides at 12 weeks |
| Secondary | Change in LDL Cholesterol (mg/dL) | Baseline and 12 weeks | LDL at baseline - LDL at 12 weeks |
| Secondary | Change in HDL Cholesterol (mg/dL) | Baseline and 12 weeks | HDL at baseline - HDL at 12 weeks |
| Secondary | Change in Alanine Aminotransferase (ALT) (U/L) | Baseline and 12 weeks | ALT at baseline - ALT at 12 weeks |
| Secondary | Change in Hemoglobin A1c (HbA1c) (%) | Baseline and 12 weeks | HbA1c at baseline - HbA1c at 12 weeks |
| Secondary | Change in % Fat Mass | Baseline and 12 weeks | % Fat mass at baseline - %Fat mass at 12 weeks measured by DEXA |
| Secondary | Change in Resting Metabolic Rate (RMR) | Baseline and 12 weeks | RMR at baseline - RMR at 12 weeks measured by indirect calorimetry |
| Secondary | Change in Daily Kilocalorie Intake | Baseline and 12 weeks | The average kilocalorie intake of 3 days was calculated each at baseline and 12 weeks. Kilocalories were calculated based on a standardized self-reported log of two weekdays and 1 weekend day. |
| Secondary | Change in Hunger | Baseline and 12 weeks | The adolescent/young adult will report subjective hunger before each meal and snack for 24 hours using a visual analogue slider scale (0= no hunger, 100 = most hunger) and this score will be averaged over the 24 hour period. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04095104/registered