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Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities — STERILE  

Peripheral Arterial Disease Clinical Trial

Official title:
Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities. THE STERILE TRIAL.

Clinical Trial Summary

The goal of this study is to evaluate whether supervised treadmill exercise combined with ranolazine 1000 mg twice daily provides an incremental benefit in absolute walking distance over supervised exercise alone in patients with stable claudication. Investigators also seek to determine if the administration of ranolazine provides a sustained benefit after the completion of a supervised exercise regimen. Lastly, investigators wish to determine whether both exercise and ranolazine improves peak oxygen consumption and anaerobic threshold in patients with stable claudication.

Clinical Trial Description

The treatment groups are:

A. Group A will be randomized to a 12 week supervised exercise program and ranolazine, (Ranexa) 1000 mg orally, twice daily, by mouth.

B. Group B will be randomized to a 12 week supervised exercise program and placebo.

After the 12 week supervised exercise program, all participants will undergo a second randomization to ranolazine or placebo for an additional 12 weeks, during which independent walking will be encouraged.

Both groups will participate in a two week lead-in period after each randomization of the trial, allowing for the stabilization of their medications and dosing of ranolazine. Medications such as cilostazol, calcium channel blockers and nitrates will be discontinued during the lead-in period, unless their use is for management for your high blood pressure. Anti-platelet (blood thinner) medications will be continued throughout the trial. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00914316
Study type Interventional
Source William Beaumont Hospitals
Contact
Status Completed
Phase N/A
Start date May 2009
Completion date March 2013
View Details
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