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Norepinephrine Transport Inhibitor

Atomoxetine for Fainting (Vasovagal Syncope) (POST7 Trial)

Phase 3
Recruiting
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 2 vasovagal syncope spells in the preceding 12 months
At least 18 years old with informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 months of the study up to 12 months
Awards & highlights

POST7 Trial Summary

This trial is testing whether atomoxetine, a drug used to treat attention deficit disorder, can prevent fainting in people with recurrent vasovagal syncope.

Who is the study for?
This trial is for adults who've fainted at least twice in the past year due to vasovagal syncope, as defined by American College of Cardiology Guidelines. Participants must be over 18 and score at least -2 on a specific Syncope Symptom Score. Those with uncontrolled blood pressure or thyroid issues, pacemakers, certain eye conditions, or taking conflicting medications cannot join.Check my eligibility
What is being tested?
The study tests if Atomoxetine Hydrochloride (40 mg twice daily) can prevent fainting in people with recurrent vasovagal syncope compared to a placebo. It's a double-blind crossover trial where patients switch between the drug and placebo after six months with a one-week break in between.See study design
What are the potential side effects?
While not specified here, common side effects of Atomoxetine may include dry mouth, nausea, decreased appetite, dizziness, trouble sleeping and mood swings. Side effects vary from person to person.

POST7 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have fainted at least twice in the last year.
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I am over 18 and understand the details of the trial.

POST7 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 months of the study up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months of the study up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The measure will be the proportion of patients having at least one syncope recurrence.
Secondary outcome measures
EQ-5D-3L
Generalized Anxiety Disorder score
Hospital Anxiety and Depression Scale (HADS)
+3 more

POST7 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: AtomoxetineActive Control1 Intervention
Atomoxetine 40 mg PO BID (morning and late afternoon) Dosing will start at 40 mg daily for 3 days1 week, followed by a forced titration to 40 mg BID, as per the FDA label for atomoxetine.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo will be identical in appearance to the active treatment pill. BID (morning and late afternoon)

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
796 Previous Clinical Trials
874,719 Total Patients Enrolled
4 Trials studying Vasovagal Syncope
204 Patients Enrolled for Vasovagal Syncope

Media Library

Atomoxetine Hydrochloride (Norepinephrine Transport Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05159687 — Phase 3
Vasovagal Syncope Research Study Groups: Placebo, Atomoxetine
Vasovagal Syncope Clinical Trial 2023: Atomoxetine Hydrochloride Highlights & Side Effects. Trial Name: NCT05159687 — Phase 3
Atomoxetine Hydrochloride (Norepinephrine Transport Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159687 — Phase 3
~92 spots leftby Sep 2026
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