Evaluation of Exercise Treadmill Test Indices in Patients With Cardiovascular Disease
This study has been terminated.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01562041
First received: March 21, 2012
Last updated: April 15, 2016
Last verified: April 2016
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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 ]
| 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 (Adult, Senior) |
| 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
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
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01562041 History of Changes |
| Other Study ID Numbers: | CPJMR0032105 |
| Study First Received: | March 21, 2012 |
| Last Updated: | April 15, 2016 |
| 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 |
Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016