CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 38 enrolled
Drug / intervention
Ranolazine +2 moredrug
Likely dose
Ranolazine 1000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01948310
NCT01948310Phase 4Completed

Effects of Ranolazine and Exercise on Daily Physical Activity Trial

Duke University·interventional·Posted Sep 23, 2013·Updated Dec 12, 2017

In Brief

A Phase 4 clinical trial evaluating Ranolazine, Aerobic Exercise, and 1 other intervention for Chronic Stable Angina. Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 23, 2013
Enrollment StartDec 1, 2013
Primary CompletionOct 10, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.8 years ago

Interventions

Ranolazinedrug

Comparison of Ranolazine 1000mg twice per day versus placebo twice per day

Aerobic Exercisebehavioral

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)

Placebodrug

Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day