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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 : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The study is designed to evaluate the use of ETT ECG indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).

Condition or disease Intervention/treatment Phase
Atherosclerotic Coronary Vascular Disease Drug: Ranolazine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Ranolazine
Ranolazine bid (twice a day) for 14 days.
 Drug: Ranolazine
twice per day for 14 days
Other Name: Ranexa®


Outcome Measures
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Primary Outcome Measures :
  1. Electrocardiogram interval times adjusted for heart rate [ Time Frame: 14 days (+/- 3 days) ]

Secondary Outcome Measures :
  1. Exercise Duration [ Time Frame: Baseline, Day 1, and Day 15 ]
  2. Time to ischemia [ Time Frame: 14 days (+/-3 days) ]
  3. Time to angina [ Time Frame: 14 days (+/-3 days) ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of stable coronary artery disease

Exclusion Criteria:

  • • 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.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01562041     History of Changes
Other Study ID Numbers: CPJMR0032105
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cardiovascular disease
Exercise Treadmill Test
Ranolazine
Angina
Myocardial ischemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Ranolazine
 Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action