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

August 6, 2008 updated by: University of Oxford

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • Department of Cardiovascular Medicine, University of Oxford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
Drug: 6R-BH4
6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo
Other Names:
  • Sapropterin dihydrochloride
Active Comparator: 1
700mg/day 6R-BH4
Drug: 6R-BH4
6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo
Other Names:
  • Sapropterin dihydrochloride
Active Comparator: 2
400mg/day 6R-BH4
Drug: 6R-BH4
6R-BH4 tablets 700mg/day, 6R-BH4 tablets 400mg/day or placebo
Other Names:
  • Sapropterin dihydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vascular function using non-invasive magnetic resonance imaging (MRI).
Time Frame: Pre- and post- treatment with 6R-BH4 or placebo
Pre- and post- treatment with 6R-BH4 or placebo

Secondary Outcome Measures

Outcome Measure
Time Frame
Laboratory measures of vascular function.
Time Frame: At time of CABG surgery
At time of CABG surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

BioMarin Pharmaceutical

Investigators

  • Principal Investigator: Keith M Channon, MD FRCP, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (Estimate)

January 18, 2007

Study Record Updates

Last Update Posted (Estimate)

August 7, 2008

Last Update Submitted That Met QC Criteria

August 6, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/Q1604/114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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