NCT01948310

Effects of Ranolazine and Exercise on Daily Physical Activity Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess whether the increased angina threshold on ranolazine and subsequent higher training intensity will result in improved exercise tolerance and oxygen consumption; and greater than that observed with exercise training on placebo. The study team anticipates the chronic exercise improvements with ranolazine will be incrementally higher than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key secondary objectives include the acute ranolazine and chronic exercise plus ranolazine effects on total daily energy expenditure (TDEE) and angina-related quality of life.

Conditions

• Chronic Stable Angina

Interventions

Type	Name	Description
DRUG	Ranolazine	Comparison of Ranolazine 1000mg twice per day versus placebo twice per day
BEHAVIORAL	Aerobic Exercise	Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
DRUG	Placebo	Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-10-10
• Completion: 2016-10-10
• First posted: 2013-09-23
• Last updated: 2017-12-12
• Results posted: 2017-12-12

Locations

1 site across 1 country: United States