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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: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT01331486 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Brachial artery flow mediated dilation max (%)
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 |
What the finished NCT01331486 record still lists
NCT01331486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo capsule is the first listed.
NCT01331486 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01331486's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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