A Proof of Principal Study of Atomoxetine for the Prevention of Vasovagal Syncope (POST6)
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|ClinicalTrials.gov Identifier: NCT02874937|
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Syncope, Vasovagal||Drug: Atomoxetine Drug: Matching Placebo||Phase 2|
Study Design: This will be a randomized, double-blind, parallel-arm study in which the subjects will undergo a tilt table test following 2 doses of atomoxetine 40mg PO (evening before and morning of study) or after 2 doses of matching placebo (on separate days). On the morning of the study, the fasting subject (except for medications) will be instrumented, on an empty bladder. ECG electrodes will be applied to monitor continuous heart rhythm. Blood pressure will be monitored continuously using a finger volume clamp method using one or more of several extant devices, and calibrated with intermittent brachial cuff measurements. One intravenous cannula will be placed in the contralateral arm (to the blood pressure cuff) for blood sampling.
Tilt Table Protocol: Following the insertion of the venous cannulae, a period of at least 20 minutes will be allowed to elapse before a 10-minute basal control (baseline) period. Baseline data will be digitally recorded in this time. In the last 5 minutes of this period, blood will be drawn for fractionated plasma catecholamines. The table will be rapidly raised to 80 degrees for up to 60 minutes. The investigators are deliberately avoiding tilt test methods with provocative medications to avoid the issue of multiple causal factors. At 10 minutes and 30 minutes following onset of tilt (or at the onset of severe presyncope or hypotension [systolic blood pressure <70 mmHg]), venous fractionated catecholamines will be sampled. The study will be terminated if the subject develops hypotension with severe presyncopal symptoms associated with a systolic blood pressure ≤70 mmHg or at the completion of the protocol.
A sample size of 56 syncope patients will have 85% power to detect a 60% relative risk reduction from a placebo outcome rate of 65%, using an unmatched 2-tailed test with alpha=0.05. To compensate for the report dropout rate the investigators will inflate the sample by 15% to 64 subjects. A formal, blinded mid-way safety and efficacy analysis will be performed with a p<0.05 stopping rule for efficacy. This also will provide 85% power to detect an 80% relative risk reduction.
Randomization will be carried out using a computerized algorithm. Patients will be randomized in a double blind fashion to receive atomoxetine 40mg PO x2 or matching placebo with a 1:1 randomization ratio. Medication containers will be centrally filled and labeled with the randomization code number.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Proof of Principal Study of Atomoxetine for the Prevention of Vasovagal Syncope (POST 6)|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||November 28, 2017|
|Actual Study Completion Date :||January 8, 2018|
Active Comparator: Atomoxetine
2 doses of atomoxetine 40mg PO (evening before and morning of study)
norepinephrine transporter inhibitor
Other Name: Apo-atomoxetine
Placebo Comparator: Placebo
2 doses of matching placebo 40 mg PO (evening before and morning of study)
Drug: Matching Placebo
matching placebo identical in appearance.
Other Name: Placebo
- Time to syncope or presyncope [ Time Frame: 1 hour ]
- systemic vascular resistance [ Time Frame: 1 hour ]
- stroke volume [ Time Frame: 1 hour ]
- cardiac output [ Time Frame: 1 hour ]
- catecholamine levels [ Time Frame: 1 hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874937
|University of Calgary, Faculty of Medicine|
|Calgary, Alberta, Canada, T2N 4N1|
|Principal Investigator:||Robert S Sheldon, MD, PhD||University of Calgary|