NCT01331486

Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prehypertension
• Mild Hypertension

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hawthorn	Hawthorn standardized extract liquid capsule
DIETARY_SUPPLEMENT	Placebo capsule	Matched placebo liquid capsule

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-04-08
• Last updated: 2013-02-07

Locations

1 site across 1 country: United States