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NCT03109795 · ClinicalTrials.gov registry record · Phase 4
Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System
A Phase 4 study, sponsored by University of Iowa.
- Terminated
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
NCT03109795 is a Phase 4 study that was terminated before completion, run by University of Iowa. The registered enrollment target is 35 participants.
The verdict
NCT03109795, a Phase 4 study, was terminated before completion, sponsored by University of Iowa.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
Study Summary
The goal of this study is to evaluate the effectiveness of a short-term (4 weeks) pharmacological blockade of sympathetic nerve activity (clonidine) on anxiety symptoms, vascular function, inflammation, muscle sympathetic nerve activity, and oxidant stress in individuals with moderate-to-high anxiety. Individuals who are interested in the study will be identified by an online screening survey and will be contacted by the research team; advertisements, flyers and mass emails will direct individuals to the online screening survey. Those deemed eligible to participate will be randomized to either the clonidine intervention or hydrochlorothiazide as a blood-pressure lowering control condition. If eligible participants are currently being treated with blood pressure-lowering medications, they will be asked to go off these medications for 2 weeks prior to and during the course of the study. During the 2 week washout of blood pressure-lowering medications, participants will have safety visits (2 additional visits) that include measurements of blood pressure at 4 days and 7 days after the beginning of the washout period before the intervention. Assessments of anxiety symptoms via various surveys, vascular function (via non-invasive, well-established techniques), inflammation, muscle sympathetic nerve activity, and oxidant stress will be performed at baseline and at the post intervention session. Similar baseline measurements will be performed in control subjects with low or no anxiety for comparison, but these individuals will not undergo the intervention. Participants with moderate-to-high anxiety will have a total of 6 visits to the laboratory, which includes the screening and consent (visit 1). Visit 2 (baseline measurements) and visit 6 (post-intervention measurements) will be more extensive (\~4.5 hours) compared to the other visits (\~30 min). Participants completing the washout will have an additional 2 visits (\~30 min each) before "visit 2." Control subjects with
Interventions
- DRUG Clonidine Pill
- DRUG Hydrochlorothiazide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2017-04-10 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03109795
The ClinicalTrials.gov registry entry for NCT03109795 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Clonidine Pill is the first listed.
NCT03109795 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03109795 about?
NCT03109795 is a clinical study titled "Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System". The goal of this study is to evaluate the effectiveness of a short-term (4 weeks) pharmacological blockade of sympathetic nerve activity (clonidine) on anxiety symptoms, vascular function, inflammation, muscle sympathetic nerve activity, and oxidant stress in individuals with moderate-to-high anxiet...
What is the current status of trial NCT03109795?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2017-04-10. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03109795?
The interventions under investigation include: Clonidine Pill (DRUG), Hydrochlorothiazide (DRUG).
Who is sponsoring clinical trial NCT03109795?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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