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

Primary Purpose

Peripheral Arterial Disease

Status

Completed

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

Ramipril

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Alfred Hospital

Outcomes

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

Full Information

NCT ID

NCT00168467

First Posted

September 9, 2005

Last Updated

January 28, 2009

Sponsor

Baker Heart Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00168467

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Baker Heart Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ramipril

Primary Outcome Measure Information:

Title

Time to onset of claudication

Title

Total exercise time during a standard treadmill test

Title

Walking ability measured using the standard Walking Impairment Questionnaire

Secondary Outcome Measure Information:

Title

Leg Blood Flow using Duplex Ultrasound

10. Eligibility

Sex

All

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bronwyn A Kingwell, PhD

Organizational Affiliation

Baker Heart Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

16670135

Citation

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.

Results Reference

result

Learn more about this trial

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

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