NCT02593110

Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Peripheral Artery Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-04
• Primary completion: 2022-05-06
• Completion: 2022-06-15
• First posted: 2015-10-30
• Last updated: 2023-01-11
• Results posted: 2023-01-11

Locations

3 sites across 1 country: United States