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

Phase 1

• Conditions: Coronary Artery Disease; MedDRA version: 8.1Level: LLTClassification code 10011078Term: Coronary artery disease

• Registration Number: EUCTR2005-006141-16-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-22
• Study Completion: 2009-06-09
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

-Male or Female, aged 18 years or above.
-Multivessel coronary artery disease scheduled to undergo coronary bypass surgery.
-Sexually active subjects must be willing to use an acceptable method of contraception while participating in the study.
-Females of childbearing potential must have a negative pregnancy test at screening and be willing to have additional pregnancy tests during the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnant or breastfeeding at screening or planning to become pregnant (subject of partner) at any time during study.
-Prior clinical diagnosis of heart failure requiring diuretic treatment with evidence of severe left ventricular dysfunction.
-Acute coronary event (unstable angina requiring hospitalisation, myocardial infarction) within the last 4 weeks.
-Emergency CABG.
-Newly diagnosed diabetes mellitus (<1 month).
-Body weight >130 kg.
-Impaired renal function (plasma creatinine > 180 µmol/l).
-Elevated liver function tests (defined as a serum alanine transaminase (ALT) >50µmol/l (or > 2x normal) and/or AST > 2x normal).
-Pacemakers, implantable defibrillators or metal implants that are not compatible with MRI scanning.
-Subjects receiving experimental medications or participating in another study using an experimental drug or experimental procedure within 30 days of enrollment into this study.
-Subject is terminally ill or is inappropriate for placebo medication.
-Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject’s ability to participate in the study.
-Requirements for concomitant treatment with any drug known to inhibit folate metabolism (e.g., methotrexate).
-Concomitant treatment with levodopa.
-Concomitant treatment with any phosphodiesterase (PDE) 5 inhibitors (e.g., Viagra®, Cialis®, Levitra®, or RevatioTM) or any PDE 3 inhibitor (e.g., cilostazol, milrinone, or vesnarinone)
-Subjects previously randomised into this study or any other clinical trial involving 6R-BH4 treatment.
-Known allergy or hypersensitivity to any excipient of 6R-BH4.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified