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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine 500 mg | Experimental | Participants received ranolazine 500 milligrams (mg), orally, twice daily (b.i.d.) up to 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine 500 mg | Drug | Ranolazine 500 mg, oral tablet, b.i.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index | ST/HR index was measured as the average change in ST segment depression relative to heart rate change over the entire duration of exercise, monitored by ECG during the exercise treadmill tests. Change in maximum ST/HR index between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Baseline up to Day 15 |
| Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Slope | ST-HR slope is an index of exercise induced ischemia. Linear regression was used to determine the slope of the ST/HR relationship in a participant's ECG response monitored during the exercise treadmill test. The highest ST segment/heart rate slope from among all the ECG leads and the X-axis intercept of the associated line were used to generate the maximum slope. Change in maximum ST-HR slope between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Baseline up to Day 15 |
| Change From Baseline in X-Axis Intercept of ST-HR Slope | Linear regression was used to determine the slope of the ST/HR relationship in a participant's ECG response monitored during the exercise treadmill test. Change in X- axis intercept of ST-HR slope between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Baseline up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Exercise Duration | Total exercise duration was defined as the elapsed time between the start of exercise and termination of exercise for severe angina, dyspnea or extreme fatigue assessed during the exercise treadmill test. Change in the duration of exercise between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. |
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Inclusion Criteria:
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.
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Jacksonville | Florida | 32216 | United States | ||
| Novartis Investigative Site |
All enrolled participants (N=14) with evidence of exercise induced ischemia [≥ 1 millimeter (mm) ST depression] on the ECG monitoring during exercise treadmill test 1 (ETT 1) and who achieved ≤ 20% variation in exercise duration between consecutive ETTs during baseline period were included in the treatment period. One participant did not provide interpretable treadmill data and was not included in the analysis of primary and secondary variables.
A total of 14 participants took part in the study from 9 March 2012 to 2 January 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine 500 mg | Participants received ranolazine, 500 mg, orally, b.i.d., up to 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set included all enrolled participants who met the inclusion/exclusion criteria and had at least one post-baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine 500 mg | Participants received ranolazine, 500 mg, orally, b.i.d., up to 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Index | ST/HR index was measured as the average change in ST segment depression relative to heart rate change over the entire duration of exercise, monitored by ECG during the exercise treadmill tests. Change in maximum ST/HR index between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Safety Analysis Set included all enrolled participants who met the inclusion/exclusion criteria and had at least one post-baseline assessment. Number analyzed were the number of participants with data available for analysis at given time point. | Posted | Mean | Standard Deviation | microvolts/beats per minute (microV/bpm) | Baseline up to Day 15 |
|
From Baseline up to end of study, approximately 21 days.
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranolazine 500 mg | Participants received ranolazine, 500 mg, orally, b.i.d., up to 14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Baseline up to Day 15 |
| Change From Baseline in Time to Onset of 1 mm ST Segment Depression (Time to Ischemia) | Exercise-induced ischemia was defined as the new development of horizontal or down sloping ST-segment depression (≥ 1 mm at 60 milliseconds after the J point) vs. baseline tracings. Change in time to onset of 1 mm ST depression between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Baseline up to Day 15 |
| Change From Baseline in Time to Onset of Angina | Time to onset of angina was defined as the elapsed time between the start of exercise and the onset of anginal chest pain as reported by the participant. Change in time to angina between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Baseline up to Day 15 |
| New York |
| New York |
| 10021 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Change From Baseline in Maximum ST Segment Change Adjusted for Heart Rate (ST-HR) Slope | ST-HR slope is an index of exercise induced ischemia. Linear regression was used to determine the slope of the ST/HR relationship in a participant's ECG response monitored during the exercise treadmill test. The highest ST segment/heart rate slope from among all the ECG leads and the X-axis intercept of the associated line were used to generate the maximum slope. Change in maximum ST-HR slope between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Safety Analysis Set included all enrolled participants who met the inclusion/exclusion criteria and had at least one post-baseline assessment. Number analyzed were the number of participants with data available for analysis at given time point. | Posted | Mean | Standard Deviation | microvolts/beat/minute (microV/beat/min) | Baseline up to Day 15 |
|
|
|
| Primary | Change From Baseline in X-Axis Intercept of ST-HR Slope | Linear regression was used to determine the slope of the ST/HR relationship in a participant's ECG response monitored during the exercise treadmill test. Change in X- axis intercept of ST-HR slope between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Safety Analysis Set included all enrolled participants who met the inclusion/exclusion criteria and had at least one post-baseline assessment. Number analyzed were the number of participants with data available for analysis at given time point. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline up to Day 15 |
|
|
|
| Secondary | Change From Baseline in Total Exercise Duration | Total exercise duration was defined as the elapsed time between the start of exercise and termination of exercise for severe angina, dyspnea or extreme fatigue assessed during the exercise treadmill test. Change in the duration of exercise between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Safety Analysis Set included all enrolled participants who met the inclusion/exclusion criteria and had at least one post-baseline assessment. Number analyzed were the number of participants with data available for analysis at given time point. | Posted | Mean | Standard Deviation | minutes | Baseline up to Day 15 |
|
|
|
| Secondary | Change From Baseline in Time to Onset of 1 mm ST Segment Depression (Time to Ischemia) | Exercise-induced ischemia was defined as the new development of horizontal or down sloping ST-segment depression (≥ 1 mm at 60 milliseconds after the J point) vs. baseline tracings. Change in time to onset of 1 mm ST depression between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Safety Analysis Set included all enrolled participants who met the inclusion/exclusion criteria and had at least one post-baseline assessment. Number analyzed were the number of participants with data available for analysis at given time point. | Posted | Mean | Standard Deviation | minutes | Baseline up to Day 15 |
|
|
|
| Secondary | Change From Baseline in Time to Onset of Angina | Time to onset of angina was defined as the elapsed time between the start of exercise and the onset of anginal chest pain as reported by the participant. Change in time to angina between the average of tests 1-3 (pre Ranexa® treatment) performed during baseline period and test 4 (post Ranexa® treatment) during treatment period was reported. | Safety Analysis Set included all enrolled participants who met the inclusion/exclusion criteria and had at least one post-baseline assessment. Number analyzed were the number of participants with data available for analysis at given time point. | Posted | Mean | Standard Deviation | minutes | Baseline up to Day 15 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 3 |
| 14 |
| DIZZINESS | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
| Test 4 |
|
| Change From Baseline in Maximum ST/Heart Rate Slope |
|
|
| Test 3 |
|
|
| Test 4 |
|
|
| Change From Baseline in X-axis Intercept of ST/Heart Rate Slope |
|
|
| Title | Measurements |
|---|---|
|
| Test 4 |
|
| Change From Baseline in Total Exercise Duration |
|
|
| Test 3 |
|
|
| Test 4 |
|
|
| Change From Baseline in Time to Onset of 1 mm ST Depression |
|
|
|
| Test 3 |
|
|
| Test 4 |
|
|
| Change From Baseline in Time to Onset of Angina |
|
|