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NCT01948310 · ClinicalTrials.gov registry record · Phase 4
Effects of Ranolazine and Exercise on Daily Physical Activity Trial
A Phase 4 study of Chronic Stable Angina, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01948310: Completed Phase 4 study of Chronic Stable Angina, sponsored by Duke University.
NCT01948310 is a Phase 4 study of Chronic Stable Angina that has completed, run by Duke University. The registered enrollment target is 38 participants, below the 178-participant average among 3 other Chronic Stable Angina trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01948310, a Phase 4 study of Chronic Stable Angina, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This test involves exercising on a treadmill or bike to maximal exertion, during which the subject's breathing and oxygen consumption are measured. Under a set study protocol, treadmill or bike workload will increase every minute until the participant either chooses to end the test or the study personnel choose to end the test for safety purposes.
Conditions Studied
Interventions
- DRUG Placebo
- BEHAVIORAL Aerobic Exercise
- DRUG Ranolazine
Study Locations (1)
North Carolina
- Duke Center for Living - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-10-10 |
| Phase | Phase 4 |
What the finished NCT01948310 record still lists
NCT01948310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 178-participant average among 3 other Chronic Stable Angina trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Chronic Stable Angina appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01948310 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01948310 about?
NCT01948310 is a clinical study titled "Effects of Ranolazine and Exercise on Daily Physical Activity Trial". 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...
What is the current status of trial NCT01948310?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2013-12. Estimated completion is 2016-10-10.
What conditions does trial NCT01948310 study?
This clinical trial studies the following conditions: Chronic Stable Angina.
What interventions are being tested in trial NCT01948310?
The interventions under investigation include: Placebo (DRUG), Aerobic Exercise (BEHAVIORAL), Ranolazine (DRUG).
Who is sponsoring clinical trial NCT01948310?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01948310 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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