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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebivolol | Active Comparator | Systolic and Diastolic blood pressure will be measured before and after randomization to12 weeks of Nebivolol. Forearm blood flow will be measured in response to 100 nmol/min of BQ-123, BQ-123+BQ788 (50 mol/min), Acetylcholine (4.0, 8.0, 16.0 ug/100 mL tissue/min), Sodium Nitroprusside (1.0, 2.0, 4.0 ug/100 mL tissue/min) and BQ-123+BQ-788+Acetylcholine (same doses as above) will be measured before and after the 12 weeks of nebivolol. |
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| Metoprolol | Active Comparator | Systolic and Diastolic blood pressure will be measured before and after randomization to12 weeks of Metoprolol. Forearm blood flow will be measured in response to 100 nmol/min of BQ-123, BQ-123+BQ788 (50 mol/min), Acetylcholine (4.0, 8.0, 16.0 ug/100 mL tissue/min), Sodium Nitroprusside (1.0, 2.0, 4.0 ug/100 mL tissue/min) and BQ-123+BQ-788+Acetylcholine (same doses as above) will be measured before and after the 12 weeks of Metoprolol. |
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| Placebo | Placebo Comparator | Systolic and Diastolic blood pressure will be measured before and after randomization to12 weeks of placebo. Forearm blood flow will be measured in response to 100 nmol/min of BQ-123, BQ-123+BQ788 (50 mol/min), Acetylcholine (4.0, 8.0, 16.0 ug/100 mL tissue/min), Sodium Nitroprusside (1.0, 2.0, 4.0 ug/100 mL tissue/min) and BQ-123+BQ-788+Acetylcholine (same doses as above) will be measured before and after the 12 weeks of placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | 5 mg tablet to be taken by mouth once per day for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Systolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention. | |
| Diastolic Blood Pressure | Diastolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention. | |
| Percent Change in Forearm Blood Flow (FBF) Response to BQ-123 (100 Nmol/Min) | Forearm blood flow (FBF) was measured via strain-gauge venous occlusion plethysmography at rest and every 10 minutes thereafter for 60 minutes. The average percent change for before and after either drug or placebo was calculated as the FBF at (each time point-resting value)/resting value and multiplied by 100 to calculate the percent change. The baseline or resting value was measured before the start of each drug infusion. | Forearm blood flow was measured at 0-60 minutes before the 12 week drug or placebo intervention and 0-60 minutes after the 12 week drug or placebo intervention. |
| Percent Change in FBF Response to BQ-123 (100 Nmol/Min) + BQ-788 (50 Nmol/Min) | Forearm blood flow (FBF) was measured via strain-gauge venous occlusion plethysmography at rest and every 10 minutes thereafter for 60 minutes. The average percent change for before and after either drug or placebo was calculated as the FBF at (each time point-resting value)/resting value and multiplied by 100 to calculate the percent change. The baseline or resting value was measured before the start of each drug infusion. | Forearm blood flow was measured 0-120 minutes before the 12 week drug or placebo intervention and 0-120 minutes after the 12 week drug or placebo intervention. |
| FBF Response to Acetylcholine (ACh) | FBF was measured via strain-gauge occlusion plethysmography at rest and in response to ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher A DeSouza, Ph.D. | University of Colorado at Boulder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC-Boulder Clinical and Translational Research Center | Boulder | Colorado | 80309 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27113048 | Derived | Diehl KJ, Stauffer BL, Dow CA, Bammert TD, Brunjes DL, Greiner JJ, DeSouza CA. Chronic Nebivolol Treatment Suppresses Endothelin-1-Mediated Vasoconstrictor Tone in Adults With Elevated Blood Pressure. Hypertension. 2016 Jun;67(6):1196-204. doi: 10.1161/HYPERTENSIONAHA.115.06979. Epub 2016 Apr 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebivolol | Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks |
| FG001 | Metoprolol | Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Metoprolol | Drug | 100 mg tablet to be taken by mouth once per day for 12 weeks |
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| Placebo | Drug | gelatin capsule to be taken by mouth once per day for 12 weeks |
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| Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min) | Other | The forearm blood flow response to the endothelin (ET) -1 A receptor blocker BQ-123 (100 nmol/min) for 60 minutes at baseline and at 12 weeks. |
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| FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min) | Other | The FBF response to the nonselective endothelin (ET) -1 receptor blockade BQ-123 (100 nmol/min) + BQ-788 (50 nmol/min)for 60 minutes at baseline and at 12 weeks. |
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| FBF response to Acetylcholine | Other | The FBF response to the endothelium-dependent vasodilator ACh (4, 8 and 16 ug/100 mL tissue/min) at baseline and at 12 weeks. |
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| FBF response to Sodium Nitroprusside | Other | The FBF response to the endothelium independent vasodilator NTP (1,2 and 4 ug/100 mL tissue/min) at baseline and at 12 weeks. |
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| FBF response to BQ-123+BQ-788+ACh | Other | The FBF response to the nonselective endothelin (ET) -1 receptor blockade BQ-123 (100 nmol/min) + BQ-788 (50 nmol/min)for 60 minutes at baseline and at 12 weeks. |
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| Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention. |
| FBF Response to Sodium Nitroprusside | FBF was measured via strain-gauge occlusion plethysmography at rest and in response to sodium nitroprusside (1.0, 2.0 and 4.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported. | Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention. |
| FBF Response to ACh in the Absence or Presence of Nonselective Endothelin A/B Blockade (BQ-123+BQ-788) | FBF was measured via strain-gauge occlusion plethysmography at rest and in response to BQ-123+BQ-788 +ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported. | Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention. |
| FG002 | Placebo | Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebivolol | Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks |
| BG001 | Metoprolol | Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks |
| BG002 | Placebo | Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| 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 | Systolic Blood Pressure | Posted | Mean | Standard Error | mmHg | Systolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention. |
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| Primary | Diastolic Blood Pressure | Posted | Mean | Standard Error | mmHg | Diastolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention. |
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| Primary | Percent Change in Forearm Blood Flow (FBF) Response to BQ-123 (100 Nmol/Min) | Forearm blood flow (FBF) was measured via strain-gauge venous occlusion plethysmography at rest and every 10 minutes thereafter for 60 minutes. The average percent change for before and after either drug or placebo was calculated as the FBF at (each time point-resting value)/resting value and multiplied by 100 to calculate the percent change. The baseline or resting value was measured before the start of each drug infusion. | Posted | Mean | Standard Error | percent change from baseline | Forearm blood flow was measured at 0-60 minutes before the 12 week drug or placebo intervention and 0-60 minutes after the 12 week drug or placebo intervention. |
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| Primary | Percent Change in FBF Response to BQ-123 (100 Nmol/Min) + BQ-788 (50 Nmol/Min) | Forearm blood flow (FBF) was measured via strain-gauge venous occlusion plethysmography at rest and every 10 minutes thereafter for 60 minutes. The average percent change for before and after either drug or placebo was calculated as the FBF at (each time point-resting value)/resting value and multiplied by 100 to calculate the percent change. The baseline or resting value was measured before the start of each drug infusion. | Posted | Mean | Standard Error | Percent change from baseline | Forearm blood flow was measured 0-120 minutes before the 12 week drug or placebo intervention and 0-120 minutes after the 12 week drug or placebo intervention. |
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| Primary | FBF Response to Acetylcholine (ACh) | FBF was measured via strain-gauge occlusion plethysmography at rest and in response to ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported. | Posted | Mean | Standard Error | mL/100 mL tissue/min | Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention. |
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| Primary | FBF Response to Sodium Nitroprusside | FBF was measured via strain-gauge occlusion plethysmography at rest and in response to sodium nitroprusside (1.0, 2.0 and 4.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported. | Posted | Mean | Standard Error | mL/100 mL tissue/min | Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention. |
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| Primary | FBF Response to ACh in the Absence or Presence of Nonselective Endothelin A/B Blockade (BQ-123+BQ-788) | FBF was measured via strain-gauge occlusion plethysmography at rest and in response to BQ-123+BQ-788 +ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported. | Posted | Mean | Standard Error | mL/100 mL tissue/min | Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention. |
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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 | Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks | 0 | 14 | 0 | 14 | 0 | 14 |
| EG001 | Metoprolol | Metoprolol: 100 mg tablet to be taken by mouth once per day for 12 weeks | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Placebo | Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks | 0 | 14 | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher DeSouza | University of Colorado | 303-492-2988 | desouzac@colorado.edu |
| ID | Term |
|---|---|
| D058246 | Prehypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| D008790 | Metoprolol |
| C072247 | cyclo(Trp-Asp-Pro-Val-Leu) |
| C086539 | BQ 788 |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| 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 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks |
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| OG004 | Before Placebo | Before randomization to placebo |
| OG005 | After Placebo | Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks |
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| OG004 | Before Placebo | Before randomization to placebo |
| OG005 | After Placebo | Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks |
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Before randomization to placebo |
| OG005 | After Placebo | Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks |
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Before randomization to placebo |
| OG005 | After Placebo | Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks |
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| Before Placebo |
Before randomization to placebo |
| OG005 | After Placebo | Placebo: gelatin capsule to be taken by mouth once per day for 12 weeks |
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