Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01331486 · ClinicalTrials.gov registry record · Phase 1
Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01331486 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants.
The verdict
NCT01331486, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Prehypertension and mild hypertension affect an estimated 157 million U.S. adults. Cardiovascular disease (CVD) risk and associated mortality is elevated in this population. Treatment options are limited consisting of lifestyle modification, which is often ineffective, or drug therapy, which carries risk of side effects. Highly safe, efficacious, and acceptable treatment options for this population are needed. Hawthorn standardized extract (HSE) is approved for use in Europe to treat heart failure, and preliminary evidence suggests it may have a blood pressure lowering effect. However, prior trials of hawthorn have based dosage recommendations on animal studies. Therefore, the investigators propose a dose-finding study to measure the pharmacodynamic effect of three doses of standardized hawthorn extract and placebo.
Interventions
- DIETARY_SUPPLEMENT Placebo capsule
- DIETARY_SUPPLEMENT Hawthorn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-05 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01331486
The ClinicalTrials.gov registry entry for NCT01331486 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo capsule is the first listed.
NCT01331486 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01331486 about?
NCT01331486 is a clinical study titled "Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract". Prehypertension and mild hypertension affect an estimated 157 million U.S. adults. Cardiovascular disease (CVD) risk and associated mortality is elevated in this population. Treatment options are limited consisting of lifestyle modification, which is often ineffective, or drug therapy, which carries...
What is the current status of trial NCT01331486?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-05. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01331486?
The interventions under investigation include: Placebo capsule (DIETARY_SUPPLEMENT), Hawthorn (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01331486?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.