Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000931976
Ethics application status
Yes
Date submitted
19/08/2011
Date registered
30/08/2011
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Telmisartan in the management of abdominal aortic aneurysm
Scientific title
The effects of Telmisartan, an angiotensinII type 1 receptor blocker, in reducing AAA growth in patients with abdominal aortic aneurysm.
Secondary ID [1] 262875 0
Nil
Universal Trial Number (UTN)
U1111-1119-8488
Trial acronym
TEDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm 261285 0
Condition category
Condition code
Cardiovascular 259433 259433 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Angiotensin II type 1 receptor blocker, oral tablet, 40mg daily for 12 months.
Intervention code [1] 264137 0
Treatment: drugs
Comparator / control treatment
Placebo, sugar pill that is identical in appearance to Telmisartan but without the active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 262240 0
Reduced AAA growth found by CT measure.
Timepoint [1] 262240 0
CT conducted every 12 months for a period of up to 5 years.
Primary outcome [2] 279510 0
Reduced AAA growth found by US measure.
Timepoint [2] 279510 0
US measured at baseline, every 6 months and at 12 months, for a duration of up to 5 years.
Secondary outcome [1] 273371 0
Ambulatory blood pressure
Timepoint [1] 273371 0
Ambulatory blood pressure measured at baseline and at 12 months, for a period of up to 5 years.
Secondary outcome [2] 287770 0
SF36 quality of life questionnaire.
Timepoint [2] 287770 0
Quality of life measured at baseline and at 12 months, for a period of up to 5 years.
Secondary outcome [3] 287771 0
Blood biomarkers (SST tubes x 2, EDTA tubes x 2, Citrate tube x 1, PaxGene tube x 1).
Timepoint [3] 287771 0
Blood biomarkers measured at entry, every 6 months and at 12 months, for a period of up to 5 years.

Eligibility
Key inclusion criteria
1. Written informed consent
2. AAA measuring a maximum diameter of 35-49 mm on CTA;
3. No current indication for AAA repair according to the treating physician or expectation that this will be revised within the next year;
4. High likelihood of compliance with treatment over 12 months;
5. No contraindications to study treatment, including: renal impairment (i.e. creatinine >1.5x upper limit of normal [ULN]), known significant renal stenosis (>70%) of one or both renal arteries, chronic liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function (i.e. ALT 1.5xULN), electrolyte imbalance and gout;
6. No current or planned usage of an AT1 blocker or ACE inhibitors.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindications to study treatment
2. Non-compliant to treatment/testing
3. Current usage of an AT1 blocker or ACE inhibitor.

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 randomisation stratified by aortic size and study site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Strateified randomisation using a computer software program (computerized sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 281721 0
State/province [1] 281721 0
Country [2] 281722 0
State/province [2] 281722 0
Country [3] 281723 0
State/province [3] 281723 0
Country [4] 281724 0
State/province [4] 281724 0
Country [5] 281725 0
State/province [5] 281725 0
Country [6] 281726 0
State/province [6] 281726 0

Funding & Sponsors
Funding source category [1] 269698 0
Other
Name [1] 269698 0
BUPA
Country [1] 269698 0
Australia
Primary sponsor type
University
Name
James Cook University
Country
Australia
Secondary sponsor category [1] 268734 0
None
Name [1] 268734 0
Country [1] 268734 0
Other collaborator category [1] 252211 0
Hospital
Name [1] 252211 0
Townsville Hospital
Country [1] 252211 0
Australia
Other collaborator category [2] 252212 0
Hospital
Name [2] 252212 0
Mater Health Services NQ Ltd
Country [2] 252212 0
Australia
Other collaborator category [3] 252213 0
Hospital
Name [3] 252213 0
Royal Brisbane Women's Hospital
Country [3] 252213 0
Australia
Other collaborator category [4] 252214 0
Hospital
Name [4] 252214 0
Fremantle Hospital
Country [4] 252214 0
Australia
Other collaborator category [5] 252215 0
Hospital
Name [5] 252215 0
Alfred Hospital
Country [5] 252215 0
Australia

Ethics approval
Ethics application status
Yes
Ethics committee name [1] 271656 0
Townsville Health Service District
Ethics committee address [1] 271656 0
Ethics committee country [1] 271656 0
Australia
Date submitted for ethics approval [1] 271656 0
08/01/2010
Approval date [1] 271656 0
12/04/2010
Ethics approval number [1] 271656 0
HREC/09/QTHS/117
Ethics committee name [2] 271657 0
JCU Human Research Ethics Committee
Ethics committee address [2] 271657 0
Ethics committee country [2] 271657 0
Australia
Date submitted for ethics approval [2] 271657 0
Approval date [2] 271657 0
12/04/2010
Ethics approval number [2] 271657 0
C7
Ethics committee name [3] 271658 0
Mater Health Services NQ Ltd
Ethics committee address [3] 271658 0
Ethics committee country [3] 271658 0
Australia
Date submitted for ethics approval [3] 271658 0
Approval date [3] 271658 0
21/09/2010
Ethics approval number [3] 271658 0
EC00412
Ethics committee name [4] 271659 0
Alfred Hospital Ethics Committee
Ethics committee address [4] 271659 0
Ethics committee country [4] 271659 0
Australia
Date submitted for ethics approval [4] 271659 0
25/02/2010
Approval date [4] 271659 0
20/05/2010
Ethics approval number [4] 271659 0
23/10/2011
Ethics committee name [5] 271660 0
Royal Brisbane and Women's Hospital Metro North Health Service District
Ethics committee address [5] 271660 0
Ethics committee country [5] 271660 0
Australia
Date submitted for ethics approval [5] 271660 0
08/01/2010
Approval date [5] 271660 0
23/06/2010
Ethics approval number [5] 271660 0
HREC/10/WRBW/28
Ethics committee name [6] 271661 0
Government of Western Australia Department of Health South Metropolitan Area Health Service
Ethics committee address [6] 271661 0
Ethics committee country [6] 271661 0
Australia
Date submitted for ethics approval [6] 271661 0
10/08/2010
Approval date [6] 271661 0
24/08/2010
Ethics approval number [6] 271661 0
1/10/0317

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Contact person for public queries
Contact person for scientific queries

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.