Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01562041
First received: March 21, 2012
Last updated: September 16, 2014
Last verified: September 2014

March 21, 2012
September 16, 2014
March 2012
January 2014   (final data collection date for primary outcome measure)
Electrocardiogram interval times adjusted for heart rate [ Time Frame: 14 days (+/- 3 days) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01562041 on ClinicalTrials.gov Archive Site
  • Exercise Duration [ Time Frame: Baseline, Day 1, and Day 15 ] [ Designated as safety issue: No ]
  • Time to ischemia [ Time Frame: 14 days (+/-3 days) ] [ Designated as safety issue: No ]
  • Time to angina [ Time Frame: 14 days (+/-3 days) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease
Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease

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

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Atherosclerotic Coronary Vascular Disease
Drug: Ranolazine
twice per day for 14 days
Other Name: Ranexa®
Ranolazine
Ranolazine bid (twice a day) for 14 days.
Intervention: Drug: Ranolazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
January 2014
January 2014   (final data collection date for primary outcome measure)

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.

Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01562041
CPJMR0032105
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2014

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