Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000236392
Ethics application status
Approved
Date submitted
5/05/2008
Date registered
8/05/2008
Date last updated
8/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Placebo controlled,randomised,crossover study of the efficacy of bosentan in the management of patients with Coronary Slow Flow Phenemenon
Scientific title
Study of bosentan in the management of angina in patients with Coronary Slow Flow phenomenon
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Slow Flow Phenomenon 3107 0
Condition category
Condition code
Cardiovascular 3266 3266 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bosentan 125mgs orally twice daily for 4 weeks with 1 week washout prior to crossover
Intervention code [1] 2848 0
Treatment: Drugs
Comparator / control treatment
matching capsule containing inactive substance orally, twice daily for 4 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 4158 0
Angina frequency
Timepoint [1] 4158 0
Week 4 and week 9 assessed by angina diary recorded by patient
Secondary outcome [1] 7050 0
Nitrate consumption
Timepoint [1] 7050 0
Week 4 and week 9 assessed by angina diary recorded by patient
Secondary outcome [2] 7051 0
Quality of life indices measured are Seattle Angina Questionnaire ,SF 36, Quality of Life Scale
Timepoint [2] 7051 0
Week 4 and week 9

Eligibility
Key inclusion criteria
Coronary Slow Flow Phenomenon. Angina frquency>3 episodes/week
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pulmonary hypertension,liver disease.Cyclosporin,glibenclamide,ketoconazole

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)
Concealment via central randomisation by fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted Block Allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 828 0
5011

Funding & Sponsors
Funding source category [1] 3351 0
Government body
Name [1] 3351 0
National Heart Foundation grant in aid
Country [1] 3351 0
Australia
Primary sponsor type
Hospital
Name
Cenral Northern Adelaide Health Service - The Queen Elizabeth Hospital
Address
28 Woodville Rd Woodville 5011
Country
Australia
Secondary sponsor category [1] 2996 0
None
Name [1] 2996 0
Address [1] 2996 0
Country [1] 2996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5377 0
Central Northern Adelaide Health Service
Ethics committee address [1] 5377 0
Ethics committee country [1] 5377 0
Australia
Date submitted for ethics approval [1] 5377 0
02/03/2006
Approval date [1] 5377 0
07/06/2006
Ethics approval number [1] 5377 0
2006039

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28565 0
Address 28565 0
Country 28565 0
Phone 28565 0
Fax 28565 0
Email 28565 0
Contact person for public queries
Name 11722 0
Dr John Beltrame
Address 11722 0
28 Woodville Rd
Woodville 5011
Country 11722 0
Australia
Phone 11722 0
+61 8 82226000
Fax 11722 0
Email 11722 0
[email protected]
Contact person for scientific queries
Name 2650 0
Dr John Beltrame
Address 2650 0
28 Woodville Rd
Woodville 5011
Country 2650 0
Australia
Phone 2650 0
+61 8 82226000
Fax 2650 0
Email 2650 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.