Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT02740660
Eligibility Criteria:
Inclusion Criteria:
* Healthy males or females with a BMI ≥ 95th percentile
* Between 12 and 17 years of age inclusive
* Tanner Stage III and above
Exclusion Criteria:
* Weigh less than 50 kg
* Have a family history of sudden death or hypertrophic cardiomyopathy
* Have a history of unexplained syncope
* Have a marked baseline prolongation of QT/QTc interval (QTc interval \>450 ms), a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or use concomitant medications that prolong the QT/QTc interval
* Have history of asthma, hypertension, thyroid disease, or significant neurologic disease such as seizure disorder
* Are pregnant, planning to become pregnant, or nursing. Females who are sexually active must be using adequate contraception.
* Take a medication known to affect weight or body composition like systemic glucocorticoids, atypical anti-psychotics, or weight loss medications
* Take beta-stimulators or beta-blockers on a regular basis
* Take stimulants for attention deficit disorder
* Take monoamine oxidase inhibitors, tricyclic antidepressants, or diuretics
* Take any chronic medication that has not had a stable dose for 1 month or longer
* Have type 1 or type 2 diabetes
* Have any significant cardiac disease (such as heart failure, arrhythmias, or valve disease), uncontrolled pulmonary disease, chronic liver disease, chronic kidney disease, or chronic infectious disease
* Have any significant psychiatric illness that is unstable or untreated such as bipolar disorder, severe depression, or severe anxiety
* Have a history of suicidal ideation
* Have an allergy or hypersensitivity to albuterol
* Are unwilling to discontinue caffeine-containing products while in the study
* Are deemed unfit to participate in the study based on evaluation by the medical investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT02740660
Study Brief:
Protocol Section:
NCT02740660