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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00168467




Registration number
NCT00168467
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
29/01/2009

Titles & IDs
Public title
The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease
Scientific title
The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease
Secondary ID [1] 0 0
20/03
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ramipril

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

Outcomes
Primary outcome [1] 0 0
Time to onset of claudication
Timepoint [1] 0 0
Primary outcome [2] 0 0
Total exercise time during a standard treadmill test
Timepoint [2] 0 0
Primary outcome [3] 0 0
Walking ability measured using the standard Walking Impairment Questionnaire
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Leg Blood Flow using Duplex Ultrasound
Timepoint [1] 0 0

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

- History of intermittent claudication (unilateral or bilateral) which was stable for 6
months

- Evidence of superficial femoral artery stenosis or occlusion on duplex scan

- Blood pressure <=160/90 mmHg

- Stable medication regimen for at least 6 months and not previously treated with ACE
inhibitors
Minimum age
No limit
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Limiting coronary artery disease

- Renal Failure

- History of hypertension

- History 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart Research Institute
Address
Country

Ethics approval
Ethics application status

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. The investigators
hypothesise that angiotensin converting enzyme inhibition (with ramipril), which causes
arterial vasodilation, also improves clinical symptoms in patients with peripheral arterial
disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00168467
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00168467