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:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT01259492
Eligibility Criteria:
Inclusion criteria:
1. Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood
2. Female patients of childbearing potential must be practicing an acceptable method of contraception.
Exclusion criteria:
1. Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2
2. History of alcohol or substance abuse within the last six months.
3. History of seizures or use of anticonvulsant medication.
4. Any psychiatric condition that requires medication or may interfere with study participation.
5. Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.
6. Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder
7. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma
8. Diagnosis or family history of Tourette's syndrome
9. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01259492
Study Brief:
Protocol Section:
NCT01259492