NCT00914316

Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities

Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities. THE STERILE TRIAL.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 high blood pressure. Anti-platelet (blood thinner) medications will be continued throughout the trial.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Ranolazine	Ranolazine, 1000 mg, capsule, twice daily, by mouth.
DRUG	Placebo	twice daily

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-06-04
• Last updated: 2017-08-09
• Results posted: 2017-08-09

Locations

1 site across 1 country: United States