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

History of Changes

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:

MedlinePlus related topics: Exercise and Physical Fitness Vascular Diseases

Drug Information available for: Ranolazine

U.S. FDA Resources

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 ]


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


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

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

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:	September 16, 2014
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 Ranolazine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions

ClinicalTrials.gov processed this record on February 27, 2015

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