Viewing Study NCT00423280



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Study NCT ID: NCT00423280
Status: UNKNOWN
Last Update Posted: 2008-08-07
First Post: 2007-01-17

Brief Title: Effect of 6R-BH4 Treatment in Coronary Artery Disease OXBIO Study
Sponsor: University of Oxford
Organization: University of Oxford

Study Overview

Official Title: A Randomised Placebo-Controlled Study of Two Doses of Oral 6R-BH4 on Vascular Function in Subjects With Coronary Artery Disease
Status: UNKNOWN
Status Verified Date: 2008-06
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to determine the effect of 6R-BH4 on vascular function in patients with coronary artery disease We hypothesize that 6R-BH4 will improve vascular function in these patients
Detailed Description: Decreased production of nitric oxide NO from the endothelium the layer of cells that forms the lining of all blood vessels has been shown to contribute to atherosclerosis NO has multiple beneficial effects on vascular function Endothelial function can be measured in humans via a number of methods and endothelial dysfunction has been shown to be a strong adverse predictor of cardiovascular events and mortality

Tetrahydrobiopterin BH4 is essential for the production of NO in endothelial cells 6R-BH4 is a synthetic version of naturally occurring BH4 We aim to investigate the effects of oral 6R-BH4 supplementation on endothelial function in patients with coronary artery disease

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None