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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
The investigators aim to evaluate subjects at high risk of future development of hypertension, those with a family history of hypertension and/or that already have high normal(SBP 120-139 mmHg or DBP 80-89 mmHg) blood pressure. The investigators plan to investigate whether these subjects have the same markers (such as microscopic protein in the urine or C-reactive protein in the blood) in the blood and urine that people with high blood pressure have, and whether they are improved before and after taking the beta-blocker nebivolol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebivolol | Experimental |
| |
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | Oral nebivolol 2.5-5mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aortic Systolic Blood Pressure (SBP) | Basline (visit 1) and 8 weeks (visit 2) | |
| Aortic Diastolic Blood Pressure (DBP) | Basline (visit 1) and 8 weeks (visit 2) | |
| Aortic Mean Arterial Pressure (MAP) | Basline (visit 1) and 8 weeks (visit 2) | |
| Aortic Pulse Pressure | Basline (visit 1) and 8 weeks (visit 2) | |
| Aortic Augmentation Pressure | Basline (visit 1) and 8 weeks (visit 2) | |
| Aortic Augmentation Index for Heart Rate | Basline (visit 1) and 8 weeks (visit 2) | |
| Pulse Wave Velocity | Basline (visit 1) and 8 weeks (visit 2) | |
| Heart Rate, Beats Per a Minute | Basline (visit 1) and 8 weeks (visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Nitric Oxide Excretion | Basline (visit 1) and 8 weeks (visit 2) | |
| Urinary Isoprostane Excretion | Basline (visit 1) and 8 weeks (visit 2) | |
| Urinary Hydrogen Peroxide Excretion |
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Inclusion Criteria:
• Prehypertensive male and female subjects with SBP =120-139 or DBP =80-89 with at least one known family member (must be diagnosed prior to the age of 60) with essential hypertension (confirmation may be sought).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel O'Connor, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States |
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Study results are being entered according to a publication that was published before PI passed away. According to the publication; two participants dropped out because of flu-like symptoms, 2 were lost to follow-up, and 1 dropped out of the study after the initial visit but never took the medication. It is unknown what arm they were in.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Oral nebivolol 5 mg once daily or Placebo (sugar pill) once dailly. Arms/Groups are combined in this module because the only access to data is a publication that was published before Principal Invesitgator passed away. According to the publication; two participants dropped out because of flu-like symptoms, 2 were lost to follow-up, and 1 dropped out of the study after the initial visit but never took the medication. It is unknown what arm they were in. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebivolol | Nebivolol: Oral nebivolol 5 mg once daily |
| BG001 | Placebo | |
| BG002 | Total |
| 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 | Aortic Systolic Blood Pressure (SBP) | Posted | Mean | Standard Deviation | mm Hg | Basline (visit 1) and 8 weeks (visit 2) |
|
|
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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 | All Study Particpants | Oral nebivolol 5 mg once daily or Placebo (sugar pill) once dailly. Arms/Groups are combined in this module because the only access to data is a publication that was published before Principal Invesitgator passed away. According to the publication; two participants dropped out because of flu-like symptoms, 2 were lost to follow-up, and 1 dropped out of the study after the initial visit but never took the medication. It is unknown what arm they were in. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flue like symptoms | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joachim H. Ix, MD, MAS | Univeristy of California, San Diego | 858-552-7528 | joeix@ucsd.edu |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular 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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| Baseline (visit 1) and 8 Weeks (visit 2) |
| Plasma Interleukin Levels | Basline (visit 1) and 8 weeks (visit 2) |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Starting systolic blood pressure | Mean | Standard Deviation | mm Hg |
|
| Starting diastolic blood pressure | Mean | Standard Deviation | mm Hg |
|
|
| Primary | Aortic Diastolic Blood Pressure (DBP) | Posted | Mean | Standard Deviation | mm Hg | Basline (visit 1) and 8 weeks (visit 2) |
|
|
|
| Primary | Aortic Mean Arterial Pressure (MAP) | Posted | Mean | Standard Deviation | mm Hg | Basline (visit 1) and 8 weeks (visit 2) |
|
|
|
| Primary | Aortic Pulse Pressure | Posted | Mean | Standard Deviation | mm Hg | Basline (visit 1) and 8 weeks (visit 2) |
|
|
|
| Primary | Aortic Augmentation Pressure | Posted | Mean | Standard Deviation | mm Hg | Basline (visit 1) and 8 weeks (visit 2) |
|
|
|
| Primary | Aortic Augmentation Index for Heart Rate | Posted | Mean | Standard Deviation | percentage | Basline (visit 1) and 8 weeks (visit 2) |
|
|
|
| Primary | Pulse Wave Velocity | Posted | Mean | Standard Deviation | m/s | Basline (visit 1) and 8 weeks (visit 2) |
|
|
|
| Primary | Heart Rate, Beats Per a Minute | Posted | Mean | Standard Deviation | beats per a minute | Basline (visit 1) and 8 weeks (visit 2) |
|
|
|
| Secondary | Urinary Nitric Oxide Excretion | Posted | Mean | Standard Deviation | umol/ mg Cr | Basline (visit 1) and 8 weeks (visit 2) |
|
|
|
| Secondary | Urinary Isoprostane Excretion | Posted | Mean | Standard Deviation | pg/ mg Cr | Basline (visit 1) and 8 weeks (visit 2) |
|
|
|
| Secondary | Urinary Hydrogen Peroxide Excretion | Posted | Mean | Standard Error | umol/ mg Cr | Baseline (visit 1) and 8 Weeks (visit 2) |
|
|
|
| Secondary | Plasma Interleukin Levels | Posted | Mean | Standard Deviation | pg/ mL | Basline (visit 1) and 8 weeks (visit 2) |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
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| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |