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The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168467
First Posted: September 15, 2005
Last Update Posted: January 29, 2009
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baker Heart Research Institute
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease Drug: Ramipril Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Baker Heart Research Institute:

Primary Outcome Measures:
  • Time to onset of claudication
  • Total exercise time during a standard treadmill test
  • Walking ability measured using the standard Walking Impairment Questionnaire

Secondary Outcome Measures:
  • Leg Blood Flow using Duplex Ultrasound

Estimated Enrollment: 40
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Limiting coronary artery disease
  • Renal Failure
  • History of hypertension
  • History of type 2 diabetes mellitus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168467


Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Baker Heart Research Institute
Investigators
Principal Investigator: Bronwyn A Kingwell, PhD Baker Heart Research Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00168467     History of Changes
Other Study ID Numbers: 20/03
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: January 29, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents