Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01562041
First received: March 21, 2012
Last updated: October 15, 2013
Last verified: October 2013
  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: 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:

Primary Outcome Measures:
  • Electrocardiogram interval times adjusted for heart rate [ Time Frame: 14 days (+/- 3 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562041

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, Florida
Novartis Investigative Site Not yet recruiting
Jacksonville, Florida, United States, 32216
United States, New York
Novartis Investigative Site Recruiting
New York, New York, United States, 10021
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01562041     History of Changes
Other Study ID Numbers: CPJMR0032105
Study First Received: March 21, 2012
Last Updated: October 15, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014