Attention Deficit Hyperactivity DisorderNCT07858448
Cardiovascular Safety of Atomoxetine in Children With ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 3 to 16 years with attention-deficit/hyperactivity disorder who are planned to start atomoxetine therapy at Assiut University Children Hospital.
Who may be able to join
- 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
Who cannot join
- Congenital heart disease
- History of clinically significant cardiac arrhythmias
- Hypertension
- Known prolonged QT syndrome
- Current treatment with medications affecting heart rate or QT interval
- Previous atomoxetine treatment
- Any clinically significant cardiovascular finding requiring specialist evaluation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cardiovascular Safety of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder: A Prospective Observational Cohort Study
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.
Read the detailed description
Atomoxetine is a selective norepinephrine reuptake inhibitor used in the treatment of ADHD. Because of its noradrenergic activity, it may affect cardiovascular parameters such as heart rate and blood pressure.
This observational study will include children aged 3 to 16 years with ADHD who will initiate atomoxetine therapy at enrollment. Resting heart rate, blood pressure, and electrocardiographic parameters will be assessed at baseline and at 6 months.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Atomoxetine, Cardiovascular safety, ADHD, Heart rate, Blood pressure, Assiut
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Children with ADHD starting atomoxetine | Children aged 3 to 16 years with ADHD who will receive atomoxetine therapy and undergo cardiovascular assessment at baseline and at 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting heart rate
Mean change in resting heart rate in beats per minute from baseline to 6 months.
Measured: At 6 months
Secondary outcomes (4)
Change in systolic blood pressure
Mean change in systolic blood pressure in mmHg from baseline to 6 months.
Measured: At 6 months
Change in diastolic blood pressure
Mean change in diastolic blood pressure in mmHg from baseline to 6 months.
Measured: At 6 months
Change in corrected QT interval
Mean change in corrected QT interval (QTc) in milliseconds from baseline to 6 months.
Measured: At 6 months
Proportion of children with cardiovascular adverse events
Proportion of children who experience cardiovascular adverse events such as palpitations or syncope during the study period.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Abdelwarith Sayed, Assiut University
- Investigators
- Mohamed A Amir, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858448
- Sponsor's protocol ID
- Atomoxetine-CV-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Safety of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07858448
- Acronym / sponsor ID
- Atomoxetine-CV-Assiut-2026
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Atomoxetine, Cardiovascular safety, ADHD, Heart rate, Blood pressure, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Atomoxetine is a selective norepinephrine reuptake inhibitor used in the treatment of ADHD. Because of its noradrenergic activity, it may affect cardiovascular parameters such as heart rate and blood pressure.
This observational study will include children aged 3 to 16 years with ADHD who will initiate atomoxetine therapy at enrollment. Resting heart rate, blood pressure, and electrocardiographic parameters will be assessed at baseline and at 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Children with ADHD starting atomoxetine | – | –Children aged 3 to 16 years with ADHD who will receive atomoxetine therapy and undergo cardiovascular assessment at baseline and at 6 months. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 3 to 16 years with attention-deficit/hyperactivity disorder who are planned to start atomoxetine therapy at Assiut University Children Hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Congenital heart disease
- History of clinically significant cardiac arrhythmias
- Hypertension
- Known prolonged QT syndrome
- Current treatment with medications affecting heart rate or QT interval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in resting heart rate
Time frame: At 6 months
Mean change in resting heart rate in beats per minute from baseline to 6 months.
4 secondary outcomes
Change in systolic blood pressure
Time frame: At 6 months
Change in diastolic blood pressure
Time frame: At 6 months
Change in corrected QT interval
Time frame: At 6 months
Proportion of children with cardiovascular adverse events
Time frame: At 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed A Amir, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya A Sayed, Resident (+20 11 47657483, ayaabdelwarith@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting heart rate (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.