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Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease

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.
 
ClinicalTrials.gov Identifier: NCT01562041
Recruitment Status : Terminated
First Posted : March 23, 2012
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 21, 2012
First Posted Date  ICMJE March 23, 2012
Last Update Posted Date August 25, 2020
Study Start Date  ICMJE March 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
Electrocardiogram interval times adjusted for heart rate [ Time Frame: 14 days (+/- 3 days) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease
Official Title  ICMJE Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Atherosclerotic Coronary Vascular Disease
Intervention  ICMJE Drug: Ranolazine
twice per day for 14 days
Other Name: Ranexa®
Study Arms  ICMJE Ranolazine
Ranolazine bid (twice a day) for 14 days.
Intervention: Drug: Ranolazine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 16, 2014)
11
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2012)
30
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562041
Other Study ID Numbers  ICMJE CPJMR0032105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP