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Lack of patient recruitment
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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in cardiovascular patients who are not able to tolerate conventional beta blockers. A side effect profile will be tracked and compared with previous beta blocker use.
The investigators hypothesize that Bystolic will be tolerated by many patients who are intolerant of conventional blockers.
Patients who have been prescribed standard beta blockers but were unable to tolerate them due to side effects will be studied. They will take a new beta blocker, Nebivolol (Bystolic) for 30 days, if tolerated. Side effects will be tracked and compared to previous.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebivolol | Experimental | Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Intolerance of Bystolic, Measured by Side Effect(s) That Lead to Discontinuance of Bystolic by the Patient and/or the Physician | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Termination of Bystolic Stratified by Reason | 30 Days | |
| Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker | 30 Days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graham | Minneapolis Heart Institute Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis Heart Institute at Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18402537 | Background | Wojciechowski D, Papademetriou V. Beta-blockers in the management of hypertension: focus on nebivolol. Expert Rev Cardiovasc Ther. 2008 Apr;6(4):471-9. doi: 10.1586/14779072.6.4.471. | |
| 16373195 | Background | Weber MA. The role of the new beta-blockers in treating cardiovascular disease. Am J Hypertens. 2005 Dec;18(12 Pt 2):169S-176S. doi: 10.1016/j.amjhyper.2005.09.009. |
| Label | URL |
|---|---|
| Minneapolis Heart Institute | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebivolol | Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control. Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebivolol | Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control. Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Intolerance of Bystolic, Measured by Side Effect(s) That Lead to Discontinuance of Bystolic by the Patient and/or the Physician | Posted | Count of Participants | Participants | 30 Days |
|
|
Adverse event information collected out to 30 days
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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 | Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control. Nebivolol: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight Gain/Edema | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Minneapolis Heart Institute Foundation | 612-863-3900 | scott.sharkey@allina.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Number of Participants With Mild Symptoms |
Mild symptoms include weight gain, edema, and headaches |
| 30 Days |
| 16923412 | Background | Kramer JM, Hammill B, Anstrom KJ, Fetterolf D, Snyder R, Charde JP, Hoffman BS, Allen LaPointe N, Peterson E. National evaluation of adherence to beta-blocker therapy for 1 year after acute myocardial infarction in patients with commercial health insurance. Am Heart J. 2006 Sep;152(3):454.e1-8. doi: 10.1016/j.ahj.2006.02.030. |
| Minneapolis Heart Institute Foundation | View source |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Participants With Termination of Bystolic Stratified by Reason | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| Secondary | Incidence of Same Symptom Stopping Bystolic as Previous Beta Blocker | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| Secondary | Number of Participants With Mild Symptoms | Mild symptoms include weight gain, edema, and headaches | Posted | Number | participants | 30 Days |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| Headache | General disorders | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular 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 |