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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT00890292
Eligibility Criteria:
Inclusion Criteria:
* Boys and girls with a Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of ADHD
* Height and weight within the 5th to 95th Physical Growth National Center for Health Statistics percentiles for age and sex
* Clinically stable with no changes in the management of ADHD for at least 1 week prior to screening
* Clinical Global Impression of Severity of Illness (CGI-S) score must be 3 or less at screening
* Children who are capable of providing assent (typically 7 years of age and older) must sign an assent form
Exclusion Criteria:
* History of or current clinically significant medical illness
* DSM-IV diagnosis of psychiatric disorder other than ADHD
* Have taken methylphenidate, amphetamine, or other stimulant medications within 5 half-lives before screening or atomoxetine within 30 days of screening
* Use of any prescription or nonprescription medication except for acetaminophen within 14 days before planned dosing of the study drug
* Positive test for drugs of abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT00890292
Study Brief:
Protocol Section:
NCT00890292