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

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Trial Status Unknown

Trial Identifier

NCT00423280

Condition

Coronary Artery Disease

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial 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.

Eligibility Criteria

Birth Sex

All

Age

From 18 Years

Healthy Volunteers

No

Drug/Treatment:

6R-BH4

Phase:

Phase 2

Study Type:

Interventional

Number of Participants:

66

Study Started:

2006-11

Study Updated:

2008-08-07

Trial Locations

  • Department of Cardiovascular Medicine, University of Oxford

    Oxford, , United Kingdom

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 inhibitor

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