Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

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

TypeCitations or Other Details
Journal Ahimastos AA, Lawler A, Reid CM, Blombery PA, King... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00168467