Peripheral Arterial DiseasePhase 4NCT00168467
The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease
A Phase 4 study testing Ramipril in people with Peripheral Arterial Disease, run by Baker Heart Research Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Ramipril
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Limiting coronary artery disease
- Renal Failure
- History of hypertension
- History of type 2 diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Ramipril
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of claudication
Total exercise time during a standard treadmill test
Walking ability measured using the standard Walking Impairment Questionnaire
Secondary outcomes (1)
Leg Blood Flow using Duplex Ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Baker Heart Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Bronwyn A Kingwell, PhD, Principal investigator, Baker Heart Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168467
- Sponsor's protocol ID
- 20/03
- Status last verified
- Jan 2009
- First submitted
- 9 Sep 2005
- Last updated
- 29 Jan 2009
- Results posted
- No
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. doi: 10.7326/0003-4819-144-9-200605020-00009.
PubMed 16670135
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00168467
- Acronym / sponsor ID
- 20/03
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Baker Heart Research InstituteUniversity, hospital or other
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Limiting coronary artery disease
- Renal Failure
- History of hypertension
- History of type 2 diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramipril | Drug | – |
Primary outcome
Time to onset of claudication
Total exercise time during a standard treadmill test
Walking ability measured using the standard Walking Impairment Questionnaire
1 secondary outcome
Leg Blood Flow using Duplex Ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
- Results publication: PubMed 16670135Ahimastos 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. doi: 10.7326/0003-4819-144-9-200605020-00009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bronwyn A Kingwell, PhD principal investigator
Baker Heart Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ramipril in people with Peripheral Arterial Disease, run by Baker Heart Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to onset of claudication. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00168467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2009.