Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease
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ClinicalTrials.gov Identifier: NCT01562041 |
Recruitment Status :
Terminated
First Posted : March 23, 2012
Last Update Posted : August 25, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atherosclerotic Coronary Vascular Disease | Drug: Ranolazine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
---|---|
Ranolazine
Ranolazine bid (twice a day) for 14 days.
|
Drug: Ranolazine
twice per day for 14 days
Other Name: Ranexa® |
- Electrocardiogram interval times adjusted for heart rate [ Time Frame: 14 days (+/- 3 days) ]
- Exercise Duration [ Time Frame: Baseline, Day 1, and Day 15 ]
- Time to ischemia [ Time Frame: 14 days (+/-3 days) ]
- Time to angina [ Time Frame: 14 days (+/-3 days) ]

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Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History of stable coronary artery disease
Exclusion Criteria:
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• Inability or unwillingness to participate in multiple exercise treadmill tests and/or any other requirements of this study as assessed by the Investigator.
- History of chronic atrial fibrillation.
Other protocol-defined inclusion/exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562041
United States, Florida | |
Novartis Investigative Site | |
Jacksonville, Florida, United States, 32216 | |
United States, New York | |
Novartis Investigative Site | |
New York, New York, United States, 10021 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01562041 |
Other Study ID Numbers: |
CPJMR0032105 |
First Posted: | March 23, 2012 Key Record Dates |
Last Update Posted: | August 25, 2020 |
Last Verified: | April 2016 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Cardiovascular disease Exercise Treadmill Test Ranolazine Angina Myocardial ischemia |
Cardiovascular Diseases Vascular Diseases Ranolazine |
Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |