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Effects of Ranolazine and Exercise on Daily Physical Activity Trial

NCT01948310 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-12-12

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • William E Kraus, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-10-10
Completion
2016-10-10

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01948310 on ClinicalTrials.gov