Cardiovascular Safety of Atomoxetine in Children With ADHD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-16
SponsorAssiut University
About this trial
This prospective observational cohort study aims to evaluate the cardiovascular safety of atomoxetine therapy in children with attention-deficit/hyperactivity disorder during the first six months of treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 3 to 16 years
Diagnosis of ADHD according to DSM-5 criteria
Planned initiation of atomoxetine therapy
Written informed consent from parents or legal guardians
Disqualifiers
Congenital heart disease
History of clinically significant cardiac arrhythmias
Hypertension
Known prolonged QT syndrome
Trial population
Children aged 3 to 16 years with attention-deficit/hyperactivity disorder who are planned to start atomoxetine therapy at Assiut University Children Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
82 Participants
are grouped into 1 trial groupGroup A: Single cohort: Children with ADHD starting atomoxetine
Trial outcomes
Primary outcomes
1
Change in resting heart rate
Mean change in resting heart rate in beats per minute from baseline to 6 months.
Time frame
At 6 monthsSecondary outcomes
1
Change in systolic blood pressure
Mean change in systolic blood pressure in mmHg from baseline to 6 months.
Time frame
At 6 months2
Change in diastolic blood pressure
Mean change in diastolic blood pressure in mmHg from baseline to 6 months.
Time frame
At 6 months3
Change in corrected QT interval
Mean change in corrected QT interval (QTc) in milliseconds from baseline to 6 months.
Time frame
At 6 months4
Proportion of children with cardiovascular adverse events
Proportion of children who experience cardiovascular adverse events such as palpitations or syncope during the study period.
Time frame
At 6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: