Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based Continuous Performance Test. Following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male or female patients who are at least 6 years of age, and who will not have reached their 13th birthday
- Diagnosis of ADHD
- Normal intelligence
- Able to swallow capsules
Exclusion criteria
- Weight less than 20 kg or more than 60 kg at study entry
- Prior treatment with atomoxetine
- History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
- History of severe allergies or multiple adverse drug reactions
- Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT prolongation, inherited cardiac disorders
Trial design
Primary purpose
Allocation
Interventional model
Masking
125 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal