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Telmisartan + Supervised Treadmill Exercise Therapy for Peripheral Arterial Disease (TELEX Trial)
N/A
Waitlist Available
Led By Mary McDermott, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All participants will have PAD. PAD will be defined as follows. First, an ABI <= 0.90 at the baseline study visit is an inclusion criterion for PAD. Second, potential participants who have an ABI > 0.90 but ≤ 1.00 and experience a 20% or higher drop in ABI after heel-rise exercise will be eligible. Third, potential participants with an ABI > 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD will be eligible. Finally, potential participants with a history of lower extremity revascularization who do not meet the criterion above and have an ABI > 0.90 with a 20% or higher drop in ABI after heel-rise exercise will be eligible.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to six-month follow-up
Awards & highlights
TELEX Trial Summary
This study is evaluating whether a drug used to treat high blood pressure may help improve walking ability in individuals with peripheral artery disease.
Eligible Conditions
- Peripheral Arterial Disease
TELEX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTELEX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to six-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to six-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Six-minute Walk Performance
Secondary outcome measures
Maximal Treadmill Walking Distance
SF-36 Physical Functioning Score
Walking Impairment Questionnaire (WIQ) Distance Score
+2 moreOther outcome measures
Calf muscle biopsy measures
TELEX Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Telmisartan + Supervised Treadmill Exercise TherapyActive Control2 Interventions
Participants in this group will receive both daily telmisartan and supervised treadmill exercise three days weekly for six months.
Group II: Telmisartan + "No Exercise" Control GroupActive Control2 Interventions
Participants in this group will receive daily telmisartan and attend weekly educational lectures at the medical center for six months.
Group III: Placebo + Supervised Treadmill Exercise TherapyActive Control2 Interventions
Participants randomized to this group will receive daily placebo and supervised treadmill exercise three times weekly for six months.
Group IV: Placebo + "No Exercise" Control GroupPlacebo Group2 Interventions
Participants randomized to this group will receive daily placebo and health education lectures weekly for six months.
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,576 Previous Clinical Trials
911,808 Total Patients Enrolled
24 Trials studying Peripheral Arterial Disease
4,308 Patients Enrolled for Peripheral Arterial Disease
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,290,761 Total Patients Enrolled
52 Trials studying Peripheral Arterial Disease
108,822 Patients Enrolled for Peripheral Arterial Disease
Mary McDermott, MD5.01 ReviewsPrincipal Investigator - Northwestern University
Northwestern University
11 Previous Clinical Trials
1,770 Total Patients Enrolled
11 Trials studying Peripheral Arterial Disease
1,770 Patients Enrolled for Peripheral Arterial Disease
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