Effect of 6R-BH4 Treatment in Coronary Artery Disease (OXBIO Study)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by University of Oxford.
Recruitment status was Recruiting

Sponsor:

Collaborator:

BioMarin Pharmaceutical

Information provided by:

University of Oxford

ClinicalTrials.gov Identifier:

NCT00423280

First received: January 17, 2007

Last updated: August 6, 2008

Last verified: June 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

January 17, 2007

Last Updated Date

August 6, 2008

Start Date ^ICMJE

November 2006

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Vascular function using non-invasive magnetic resonance imaging (MRI). [ Time Frame: Pre- and post- treatment with 6R-BH4 or placebo ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Improvement in measures of vascular function using non-invasive magnetic resonance imaging (MRI).

Change History

Complete list of historical versions of study NCT00423280 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Laboratory measures of vascular function. [ Time Frame: At time of CABG surgery ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Improvement in laboratory measures of vascular function.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of 6R-BH4 Treatment in Coronary Artery Disease (OXBIO Study)

Official Title ^ICMJE

A Randomised, Placebo-Controlled Study of Two Doses of Oral 6R-BH4 on Vascular Function in Subjects With Coronary Artery Disease

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Drug: 6R-BH4

6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo

Other Name: Sapropterin dihydrochloride

Study Arm (s)

Active Comparator: 1
700mg/day 6R-BH4

Intervention: Drug: 6R-BH4
Active Comparator: 2
400mg/day 6R-BH4

Intervention: Drug: 6R-BH4
Placebo Comparator: 3
Placebo

Intervention: Drug: 6R-BH4

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2009

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Multi-vessel coronary artery disease scheduled for coronary artery bypass surgery (CABG)

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Colin Cunnington, MBChB MRCP

+44-1865-221866

colin.cunnington@cardiov.ox.ac.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00423280

Other Study ID Numbers ^ICMJE

06/Q1604/114

Has Data Monitoring Committee

Yes

Responsible Party

Mrs Heather House, University of Oxford

Study Sponsor ^ICMJE

University of Oxford

Collaborators ^ICMJE

BioMarin Pharmaceutical

Investigators ^ICMJE

Principal Investigator:

Keith M Channon, MD FRCP

University of Oxford

Information Provided By

University of Oxford

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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