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Difficulty with recruiting willing participants.
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The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour ambulatory blood pressure characteristics and basal metabolic rates in patients with hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoprolol to nebivolol | Experimental | metoprolol 25-200mg at a stable daily dose for 4 weeks, then change to nebivolol at a comparable stable dose (5-20 mg) for 4 -5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol | Drug | Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. | 4 weeks (pre- and post-treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Minor, PharmD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
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From 11/2008-4/2009, 472 patient were prescribed metoprolol succinate. During screening, metoprolol succinate was discontinued in 87 patients and 177 were excluded (obstacles to visits, competency issues). A national shortage of metoprolol succinate caused discontinuation in mant patients. One patient was enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metoprolol to Nebivolol | Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose. Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metoprolol to Nebivolol | Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose. Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg. |
| 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 | Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. | Posted | Mean | Standard Deviation | mm HG | 4 weeks (pre- and post-treatment) |
|
|
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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 | Metoprolol to Nebivolol | Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose. Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor of Medicine | University of Mississippi Medical Center | 601-984-5600 | DMinor@umc.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| D000068577 | Nebivolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Nebivolol | Drug | 5 - 20 mg daily, at a stable dose for 4 to 5 weeks |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| 0 |
| 1 |
| 0 |
| 1 |
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| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |