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Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562041
First Posted: March 23, 2012
Last Update Posted: April 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
The study is designed to evaluate the use of ETT ECG indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).

Condition Intervention Phase
Atherosclerotic Coronary Vascular Disease Drug: Ranolazine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

Secondary Outcome Measures:
  • 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) ]

Enrollment: 11
Study Start Date: March 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ranolazine
Ranolazine bid (twice a day) for 14 days.
Drug: Ranolazine
twice per day for 14 days
Other Name: Ranexa®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01562041     History of Changes
Other Study ID Numbers: CPJMR0032105
First Submitted: March 21, 2012
First Posted: March 23, 2012
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