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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Angiotensin Converting Enzyme (ACE) Inhibition and Peripheral Arterial Disease
Scientific title
ACE Inhibition; A Potential New Therapy for Peripheral Arterial Disease
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Ramipril or matching placebo

Treatment: Drugs: Ramipril or matching placebo
10 mg Ramipril or matching placebo once daily for 6 months

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
walking time
Timepoint [1] 0 0
baseline and 6 months
Secondary outcome [1] 0 0
walking impairment questionnaire
Timepoint [1] 0 0
baseline and 6 months

Key inclusion criteria
- Ankle brachial index of <0.9 in at least one leg

- History of intermittent claudication (unilateral or bilateral)

- A stable medication regimen for at least 6 months
Minimum age
40 Years
Maximum age
85 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Limiting coronary artery disease

- Renal failure (serum creatinine > 0.20 mmol/L)

- Current treatment or treatment within the previous 6 months with ACE inhibitors or
angiotensin II receptor antagonists

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Baker Heart Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
8008 - Melbourne

Funding & Sponsors
Primary sponsor type
Bayside Health

Ethics approval
Ethics application status

Brief summary
Leg pain caused by peripheral arterial disease (PAD) can severely impede walking ability. Our
preliminary findings indicate that the drug ramipril is much more effective in improving
walking ability than current therapies. To be accepted as a new treatment for PAD these
findings require validation in a much larger clinical trial.We propose to examine the effects
of ramipril therapy for 6 months in a randomized, controlled trial of patients with PAD. If
positive, this study will identify ramipril as a potential new therapy for PAD.
Trial website
Trial related presentations / publications
Ahimastos AA, Lawler A, Reid CM, Blombery PA, Kingwell BA. Brief communication: ramipril markedly improves walking ability in patients with peripheral arterial disease: a randomized trial. Ann Intern Med. 2006 May 2;144(9):660-4. Retraction in: Ann Intern Med. 2015 Dec 1;163(11):884.
Public notes

Principal investigator
Name 0 0
Bronwyn A Kingwell, PhD
Address 0 0
Baker Heart Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications