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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.
To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nebivolol | Experimental | Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached |
|
| Metoprolol | Active Comparator | Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nebivolol | Drug | Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Central Systolic Blood Pressure (SBP) | Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure. | Baseline and 26 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulse Wave Velocity (PWV) | To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse wave velocity. | Baseline and 26 Weeks |
| Change in Augmentation Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Bakris, M.D. | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebivolol | Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached nebivolol |
| FG001 | Metoprolol | Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached Metoprolol |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebivolol | Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached nebivolol |
| BG001 | Metoprolol | Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached Metoprolol |
| 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 in Central Systolic Blood Pressure (SBP) | Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure. | Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study. | Posted | Mean | Standard Deviation | mmHg | Baseline and 26 Weeks |
|
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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 | Nebivolol | Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached nebivolol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. George Bakris | University of Chicago | 773-702-7936 | gbakris@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Metoprolol | Drug | Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached |
|
|
Augmentation index is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection. |
| Baseline and 26 Weeks |
| Change in Pulse Pressure Amplification | To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse pressure amplification (central pulse pressure /brachial pulse pressure). | Baseline and 26 Weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Metoprolol |
Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached Metoprolol |
|
|
| Secondary | Change in Pulse Wave Velocity (PWV) | To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse wave velocity. | Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study. | Posted | Mean | Standard Deviation | m/s | Baseline and 26 Weeks |
|
|
|
| Secondary | Change in Augmentation Index | Augmentation index is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection. | Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study. | Posted | Mean | Standard Deviation | percent (%) | Baseline and 26 Weeks |
|
|
|
| Secondary | Change in Pulse Pressure Amplification | To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse pressure amplification (central pulse pressure /brachial pulse pressure). | Nine patients (4 in the Metoprolol and 5 in the Nebivolol group) discontinued the study medications early in the 26-week follow-up and did not undergo final assessment. Given that our interest was on efficacy, thus, results were reported only on those 61 patients (32 in the Metoprolol and 29 in the Nebivolol group) who completed the study. | Posted | Mean | Standard Deviation | ratio | Baseline and 26 Weeks |
|
|
|
| 0 |
| 34 |
| 8 |
| 34 |
| EG001 | Metoprolol | Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached Metoprolol | 0 | 36 | 9 | 36 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
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| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D020005 | Propanols |