Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000542695
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
28/09/2005
Date last updated
28/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Ramipril on Clinical Symptoms in Patients with Peripheral Arterial Disease
Scientific title
A randomised phase IV study to examine the effects of ramipril on walking distance in patients with peripheral arterial disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arertial Disease 669 0
Condition category
Condition code
Cardiovascular 743 743 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ramipril, 10 mg once daily (n=20) for 24 weeks.
Intervention code [1] 348 0
Treatment: Drugs
Comparator / control treatment
Placebo (n=20) for 24 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 928 0
Time to onset of claudication during a standard treadmill test.
Timepoint [1] 928 0
Measurements were made at baseline and after 24 weeks therapy with ramipril (10mg od).
Primary outcome [2] 929 0
Total exercise time during a standard treadmill test
Timepoint [2] 929 0
Measurements were made at baseline and after 24 weeks therapy with ramipril (10mg od).
Primary outcome [3] 930 0
Walking ability measured using the standard Walking Impairment Questionnaire.
Timepoint [3] 930 0
Measurements were made at baseline and after 24 weeks therapy with ramipril (10mg od).
Secondary outcome [1] 1779 0
Leg blood flow and magnitude of occlusion using Duplex ultrasound.
Timepoint [1] 1779 0
Measurements were made at baseline and after 24 weeks therapy with ramipril (10mg od).

Eligibility
Key inclusion criteria
Ankle-brachial index of <0.9 at rest in at least one legHistory of intermittent claudication (unilateral or bilateral) which was stable for 6 monthsEvidence of superficial femoral artery stenosis or occlusion on duplex scanBlood pressure <=160/90 mmHgStable medication regimen for at least 6 months and not previously treated with ACE inhibitors.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Limiting coronary artery diseaseRenal failureHistory of hypertensionHistory of type 2 diabetes mellitus.

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)
The active and placebo treatments were assigned to identical containers numbered 1-40.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Corresponding numbered slips of paper were drawn randomly from an envelope to assign patients after screening. This was done by the study co-ordinator. The envelope was kept in a secure location throughout the randomisation process.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2006
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)

Funding & Sponsors
Funding source category [1] 824 0
Government body
Name [1] 824 0
NHMRC
Country [1] 824 0
Australia
Primary sponsor type
Hospital
Name
Baker Heart Resaerch Institute / Alfred Hospital
Address
Country
Australia
Secondary sponsor category [1] 692 0
None
Name [1] 692 0
NA
Address [1] 692 0
Country [1] 692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2090 0
Alfred Hopsital
Ethics committee address [1] 2090 0
Ethics committee country [1] 2090 0
Australia
Date submitted for ethics approval [1] 2090 0
Approval date [1] 2090 0
Ethics approval number [1] 2090 0

Summary
Brief summary
One important clinical challenge in older individuals is maintaining mobility in the absence of pain. Peripheral arterial disease affects up to 12% of adults over 50 and impairs quality of life due to intermittent claudication causing pain and limiting mobility. Conventional therapies have only modest effect in improving symptoms. We hypothesise that angiotensin converting enzyme inhibition (with ramipril), which causes arterial vasodilation, also improves clinical symptoms in patients with peripheral arterial disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36089 0
Address 36089 0
Country 36089 0
Phone 36089 0
Fax 36089 0
Email 36089 0
Contact person for public queries
Name 9537 0
A/Prof Bronwyn Kingwell
Address 9537 0
Baker Heart Research Institute
PO Box 6492
St Kilda Rd Central
Melbourne VIC 8008
Country 9537 0
Australia
Phone 9537 0
+61 3 92763261
Fax 9537 0
+61 3 92762495
Email 9537 0
[email protected]
Contact person for scientific queries
Name 465 0
A/Prof Bronwyn Kingwell
Address 465 0
Baker Heart Research Institute
PO Box 6492
St Kilda Rd Central
Melbourne VIC 8008
Country 465 0
Australia
Phone 465 0
+61 3 92763261
Fax 465 0
+61 3 92762495
Email 465 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.