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Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease

NCT02593110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-01-11

Study results available
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Summary

The TELEX trial will establish whether telmisartan alone improves walking performance in people with peripheral artery disease (PAD). The TELEX trial will also determine whether telmisartan plus supervised exercise improves walking performance more than either therapy alone. TELEX is a randomized controlled clinical trial (2 x 2 factorial design) of 112 participants with PAD randomized to one of four arms: Group A: telmisartan + supervised exercise therapy; Group B: telmisartan + a "no exercise" control group; Group C: placebo + supervised exercise therapy; and Group D: placebo + a "no exercise" control group.

Conditions

Interventions

BEHAVIORAL

Supervised Treadmill Exercise Therapy

Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.

DRUG

Telmisartan

Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.

OTHER

"No exercise" control group

Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Mary McDermott, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-04
Primary Completion
2022-05-06
Completion
2022-06-15

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02593110 on ClinicalTrials.gov