Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000087358
Ethics application status
Approved
Date submitted
17/12/2007
Date registered
14/02/2008
Date last updated
14/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of tetrahydrobiopterin(BH4) in patients with angina
Scientific title
Effects of tetrahydrobiopterin (BH4) on myocardial blood flow and vascular function in coronary artery disease.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 2634 0
Condition category
Condition code
Cardiovascular 2749 2749 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Folic acid (20 mg/day) and tetrahydrobiopterin (5 mg/kg/day) for 14 days
Intervention code [1] 2369 0
Treatment: Drugs
Comparator / control treatment
Placebo- (D-glucose anhydrose) administered once a day for 14 days.
Control group
Placebo

Outcomes
Primary outcome [1] 3638 0
Endothelial dependent vasodilatation in the brachial artery measured by magnetic resonance imaging
Timepoint [1] 3638 0
outcome measured after day 14.
Secondary outcome [1] 6104 0
myocardial blood flow measured on cardiac magnetic resonance imaging
Timepoint [1] 6104 0
outcome measured after day 14.
Secondary outcome [2] 6105 0
aortic distensibility measured on cardiac magnetic resonance imaging.
Timepoint [2] 6105 0
outcome measured after day 14

Eligibility
Key inclusion criteria
stable angina
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
renal failure, unsuitable for Magnetic Resonance Imaging

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomization by central pharmacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 342 0
5042
Recruitment postcode(s) [2] 343 0
5000

Funding & Sponsors
Funding source category [1] 2889 0
University
Name [1] 2889 0
Flinders University
Country [1] 2889 0
Australia
Primary sponsor type
Government body
Name
Department of Health
Address
Southern Adelaide Health Service,
Government of South Australia
Country
Australia
Secondary sponsor category [1] 2610 0
None
Name [1] 2610 0
Address [1] 2610 0
Country [1] 2610 0
Other collaborator category [1] 109 0
Hospital
Name [1] 109 0
Department of Cardiology
Royal Adelaide Hospital
Address [1] 109 0
Adelaide
Country [1] 109 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4830 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 4830 0
Ethics committee country [1] 4830 0
Date submitted for ethics approval [1] 4830 0
Approval date [1] 4830 0
Ethics approval number [1] 4830 0
Ethics committee name [2] 4831 0
Human Ethics Committee- Royal Adelaide Hospital
Ethics committee address [2] 4831 0
Adelaide
Ethics committee country [2] 4831 0
Australia
Date submitted for ethics approval [2] 4831 0
Approval date [2] 4831 0
06/12/2007
Ethics approval number [2] 4831 0

Summary
Brief summary
The purpose of the study is to evaluate the effect of tetrahydrobiopterin (BH4) on myocardial blood flow and vascular function in patients with coronary artery disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28244 0
Address 28244 0
Country 28244 0
Phone 28244 0
Fax 28244 0
Email 28244 0
Contact person for public queries
Name 11401 0
Biju Paul
Address 11401 0
Department of Medicine
Flinders Medical Centre
Adelaide
Country 11401 0
Australia
Phone 11401 0
0882045972
Fax 11401 0
Email 11401 0
[email protected]
Contact person for scientific queries
Name 2329 0
Biju Paul
Address 2329 0
Department of Medicine
Flinders Medical Centre
Adelaide
Country 2329 0
Australia
Phone 2329 0
0882045972
Fax 2329 0
Email 2329 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.