Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease

This study is currently recruiting participants.

Verified October 2012 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01562041

First received: March 21, 2012

Last updated: October 2, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2012

Last Updated Date

October 2, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01562041 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Atherosclerotic Coronary Vascular Disease

Intervention ^ICMJE

Other: Ranolazine

twice per day for 14 days

Other Name: Ranexa®

Study Arm (s)

Ranolazine

Ranolazine bid (twice a day) for 14 days.

Intervention: Other: 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (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.

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals

+1(862)778-8300

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01562041

Other Study ID Numbers ^ICMJE

CPJMR0032105

Has Data Monitoring Committee

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

October 2012

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

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