Status:
UNKNOWN
Effect of 6R-BH4 Treatment in Coronary Artery Disease (OXBIO Study)
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
BioMarin Pharmaceutical
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 patient...
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 benefici...
Eligibility Criteria
Inclusion
- Multi-vessel coronary artery disease scheduled for coronary artery bypass surgery (CABG)
Exclusion
- Inability to provide informed consent
- Female subject who is pregnant, lactating or planning pregnancy during course of study
- Prior clinical diagnosis of heart failure requiring diuretic therapy with evidence of severe left ventricular dysfunction
- Recent acute coronary event (\<4 weeks)
- Emergency CABG
- Newly diagnosed diabetes mellitus (\<1 month)
- Body weight \>130kg
- Impaired renal function (creatinine \>180umol/l)
- Elevated liver function tests (ALT \>50umol/l or AST \>2x normal)
- Pacemakers, ICDs or metallic implants not compatible with MRI scanning
- Subjects receiving experimental medications or participating in another study
- Terminally ill subjects
- Known hypersensitivity to 6R-BH4
- Concomitant treatment with methotrexate, levodopa, PDE-3 or PDE-5 inhibitors
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00423280
Start Date
November 1 2006
End Date
February 1 2009
Last Update
August 7 2008
Active Locations (1)
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1
Department of Cardiovascular Medicine, University of Oxford
Oxford, United Kingdom, OX3 9DU