Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease

NCT ID: NCT01562041

Last Updated: 2021-06-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-09

Study Completion Date

2014-01-02

Brief Summary

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

Detailed Description

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Conditions

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Atherosclerotic Coronary Vascular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ranolazine 500 mg

Participants received ranolazine 500 milligrams (mg), orally, twice daily (b.i.d.) up to 14 days.

Group Type EXPERIMENTAL

Ranolazine 500 mg

Intervention Type DRUG

Ranolazine 500 mg, oral tablet, b.i.d.

Interventions

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Ranolazine 500 mg

Ranolazine 500 mg, oral tablet, b.i.d.

Intervention Type DRUG

Other Intervention Names

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Ranexa®

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Jacksonville, Florida, United States

Site Status

Novartis Investigative Site

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CPJMR0032105

Identifier Type: -

Identifier Source: org_study_id

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