Effect of 6R-BH4 Treatment in Coronary Artery Disease (OXBIO Study)
NCT ID: NCT00423280
Last Updated: 2008-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
66 participants
INTERVENTIONAL
2006-11-30
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
700mg/day 6R-BH4
6R-BH4
6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo
2
400mg/day 6R-BH4
6R-BH4
6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo
3
Placebo
6R-BH4
6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
6R-BH4
6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BioMarin Pharmaceutical
INDUSTRY
University of Oxford
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of Oxford
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Keith M Channon, MD FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Cardiovascular Medicine, University of Oxford
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Cunnington C, Van Assche T, Shirodaria C, Kylintireas I, Lindsay AC, Lee JM, Antoniades C, Margaritis M, Lee R, Cerrato R, Crabtree MJ, Francis JM, Sayeed R, Ratnatunga C, Pillai R, Choudhury RP, Neubauer S, Channon KM. Systemic and vascular oxidation limits the efficacy of oral tetrahydrobiopterin treatment in patients with coronary artery disease. Circulation. 2012 Mar 20;125(11):1356-66. doi: 10.1161/CIRCULATIONAHA.111.038919. Epub 2012 Feb 7.
Cunnington C, Channon KM. Tetrahydrobiopterin: pleiotropic roles in cardiovascular pathophysiology. Heart. 2010 Dec;96(23):1872-7. doi: 10.1136/hrt.2009.180430. Epub 2010 Sep 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06/Q1604/114
Identifier Type: -
Identifier Source: org_study_id