PrehypertensionPhase 4NETSNCT01395329

Nebivolol and the Endothelin (ET)-1 System

A Phase 4 study testing Nebivolol, Metoprolol and Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min) in people with Prehypertension and Hypertension, run by University of Colorado, Boulder at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Prehypertension, Hypertension
What is being tested?: Nebivolol, Metoprolol and Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteUnited States
Study dates: May 2011to Dec 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.
Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure >130 mmHg and < 160 mm Hg and/or diastolic blood pressure >80 mmHg and < 100 mm Hg.
All of the women in the study will be postmenopausal (at least 1 year from last menstrual cycle) and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
Lastly, candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study.

Who cannot join

Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits)
Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication an aspirin) medications will not be eligible.
Fasting plasma glucose >126 mg/dL.
Potential candidates with a resting heart rate of < 50 beats/minute will be excluded.
Use of hormone replacement therapy.
In hypertensive subjects, a seated systolic blood pressure greater than 160 mmHg or a seated diastolic blood pressure greater than 100 mmHg.

Trial locations and contacts

1 site in 1 country.

United States1 site

UC-Boulder Clinical and Translational Research Center
Boulder, Colorado, 80309

Other trials in United States

About this study

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.

Read the detailed description

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.
The investigators further hypothesize that reducing ET-1 vasoconstrictor activity contributes to the improvement in endothelial vasodilator function associated with nebivolol.

Conditions: Prehypertension, Hypertension
Being tested: Nebivolol, Metoprolol, Placebo, Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min), FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min)
Medical subject headings: Prehypertension, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NebivololDrug
Also called Bystolic
5 mg tablet to be taken by mouth once per day for 12 weeks
MetoprololDrug
Also called Toprol-XL
100 mg tablet to be taken by mouth once per day for 12 weeks
PlaceboDrug
gelatin capsule to be taken by mouth once per day for 12 weeks
Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min)Other
Also called BQ-123
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.
FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min)Other
Also called BQ-123+BQ-788
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.
FBF response to AcetylcholineOther
Also called ACh
The FBF response to the endothelium-dependent vasodilator ACh (4, 8 and 16 ug/100 mL tissue/min) at baseline and at 12 weeks.
FBF response to Sodium NitroprussideOther
Also called NTP
The FBF response to the endothelium independent vasodilator NTP (1,2 and 4 ug/100 mL tissue/min) at baseline and at 12 weeks.
FBF response to BQ-123+BQ-788+AChOther
Also called BQ-123+BQ-788+ACh
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.

Study groups in NCT01395329
Study group	Role	What they receive
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. Receives: Drug: Nebivolol; Other: Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min); Other: FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min); Other: FBF response to Acetylcholine; Other: FBF response to Sodium Nitroprusside; Other: FBF response to BQ-123+BQ-788+ACh
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. Receives: Drug: Metoprolol; Other: Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min); Other: FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min); Other: FBF response to Acetylcholine; Other: FBF response to Sodium Nitroprusside; Other: FBF response to BQ-123+BQ-788+ACh
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. Receives: Drug: Placebo; Other: Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min); Other: FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min); Other: FBF response to Acetylcholine; Other: FBF response to Sodium Nitroprusside; Other: FBF response to BQ-123+BQ-788+ACh

What is being measured

The primary outcome is the main question the study is designed to answer.

Systolic Blood Pressure
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Dec 2016

First posted15 Jul 2011 (estimated)
Study startMay 2011
Primary completionNov 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PrehypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01395329
Sponsor's protocol ID: BYS-MD-57
Acronym: NETS
Status last verified: Dec 2018
First submitted: 9 Jun 2011
Last updated: 2 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 27113048

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nebivolol and the Endothelin (ET)-1 System
ClinicalTrials.gov ID: NCT01395329
Acronym / sponsor ID: NETS / BYS-MD-57
Conditions: Prehypertension, Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: University of Colorado, BoulderUniversity, hospital or other
Collaborators: Forest Laboratories
Study start: May 2011
Primary completion: Nov 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 15 Jul 2011 (estimated)
Results: Posted 6 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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.
The investigators further hypothesize that reducing ET-1 vasoconstrictor activity contributes to the improvement in endothelial vasodilator function associated with nebivolol.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Nebivolol	Active comparator	Drug: Nebivolol, Other: Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min), Other: FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min), Other: FBF response to Acetylcholine, Other: FBF response to Sodium Nitroprusside, Other: FBF response to BQ-123+BQ-788+AChSystolic 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.
Metoprolol	Active comparator	Drug: Metoprolol, Other: Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min), Other: FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min), Other: FBF response to Acetylcholine, Other: FBF response to Sodium Nitroprusside, Other: FBF response to BQ-123+BQ-788+AChSystolic 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.
Placebo	Placebo comparator	Drug: Placebo, Other: Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min), Other: FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min), Other: FBF response to Acetylcholine, Other: FBF response to Sodium Nitroprusside, Other: FBF response to BQ-123+BQ-788+AChSystolic 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.

Who may qualify

Ages: 45 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.
Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure >130 mmHg and < 160 mm Hg and/or diastolic blood pressure >80 mmHg and < 100 mm Hg.
All of the women in the study will be postmenopausal (at least 1 year from last menstrual cycle) and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
Lastly, candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study.

Key exclusion criteria (6 listed)

Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits)
Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication an aspirin) medications will not be eligible.
Fasting plasma glucose >126 mg/dL.
Potential candidates with a resting heart rate of < 50 beats/minute will be excluded.
Use of hormone replacement therapy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NebivololAlso: Bystolic5 mg tablet to be taken by mouth once per day for 12 weeks	Drug	Nebivolol
MetoprololAlso: Toprol-XL100 mg tablet to be taken by mouth once per day for 12 weeks	Drug	Metoprolol
Placebogelatin capsule to be taken by mouth once per day for 12 weeks	Drug	Placebo
Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min)Also: BQ-123The 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.	Other	Metoprolol, Nebivolol, Placebo
FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min)Also: BQ-123+BQ-788The 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.	Other	Metoprolol, Nebivolol, Placebo
FBF response to AcetylcholineAlso: AChThe FBF response to the endothelium-dependent vasodilator ACh (4, 8 and 16 ug/100 mL tissue/min) at baseline and at 12 weeks.	Other	Metoprolol, Nebivolol, Placebo
FBF response to Sodium NitroprussideAlso: NTPThe FBF response to the endothelium independent vasodilator NTP (1,2 and 4 ug/100 mL tissue/min) at baseline and at 12 weeks.	Other	Metoprolol, Nebivolol, Placebo
FBF response to BQ-123+BQ-788+AChAlso: BQ-123+BQ-788+AChThe 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.	Other	Metoprolol, Nebivolol, Placebo

Primary outcome

Systolic Blood Pressure
Time frame: 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
Time frame: 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)
Time frame: 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.
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.
Percent Change in FBF Response to BQ-123 (100 Nmol/Min) + BQ-788 (50 Nmol/Min)
Time frame: 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.
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.
FBF Response to Acetylcholine (ACh)
Time frame: Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
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.
FBF Response to Sodium Nitroprusside
Time frame: Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
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.
FBF Response to ACh in the Absence or Presence of Nonselective Endothelin A/B Blockade (BQ-123+BQ-788)
Time frame: Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
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.

Results and safety

Results posted to the registry on 6 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nebivolol	14	14
Metoprolol	14	14
Placebo	14	14

Primary outcome: Systolic Blood Pressure

Time frame: Systolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.. Mean (Standard Error). Unit: mmHg

Measure	Before Nebivolol n = 14	After Nebivolol n = 14	Before Metoprolol n = 14	After Metoprolol n = 14	Before Placebo n = 14	After Placebo n = 14
Value	144 (6.6)	126 (7.8)	140 (6.1)	125 (9.3)	139 (4.9)	134 (8.3)

Primary outcome: Diastolic Blood Pressure

Time frame: Diastolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.. Mean (Standard Error). Unit: mmHg

Measure	Before Nebivolol n = 14	After Nebivolol n = 14	Before Metoprolol n = 14	After Metoprolol n = 14	Before Placebo n = 14	After Placebo n = 14
Value	89 (5.2)	77 (5.3)	90 (7.6)	77 (4.8)	86 (7.7)	83 (7.3)

Primary outcome: Percent Change in Forearm Blood Flow (FBF) Response to BQ-123 (100 Nmol/Min)

Time frame: 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.. Mean (Standard Error). Unit: percent change from baseline

Measure	Before Nebivolol n = 14	After Nebivolol n = 14	Before Metoprolol n = 14	After Metoprolol n = 14	Before Placebo n = 14	After Placebo n = 14
BQ-123 10 min	10.2 (2.6)	-1.0 (1.7)	10.0 (3.7)	11.1 (2.8)	13.1 (4.6)	15.7 (3.0)
BQ-123 20 min	17.4 (3.3)	6.0 (3.3)	18.0 (4.7)	18.7 (3.2)	20.4 (3.1)	14.7 (3.9)
BQ-123 30 min	22.3 (5.1)	-1.1 (3.3)	23.0 (4.6)	21.1 (4.8)	26.8 (5.1)	23.3 (4.5)
BQ-123 40 min	25.6 (6.3)	3.8 (3.2)	28.4 (4.9)	28.9 (3.8)	23.9 (4.3)	25.7 (3.9)
BQ-123 50 min	25.8 (4.6)	6.1 (3.6)	31.4 (5.9)	27.7 (4.8)	29.0 (5.6)	26.5 (4.5)
BQ-123 60 min	27.0 (6.4)	1.1 (4.5)	34.4 (5.7)	30.6 (5.5)	33.8 (5.3)	30.4 (3.7)

Primary outcome: Percent Change in FBF Response to BQ-123 (100 Nmol/Min) + BQ-788 (50 Nmol/Min)

Time frame: 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.. Mean (Standard Error). Unit: Percent change from baseline

Measure	Before Nebivolol n = 14	After Nebivolol n = 14	Before Metoprolol n = 14	After Metoprolol n = 14	Before Placebo n = 14	After Placebo n = 14
BQ-123 10 min	10.2 (2.6)	-1.0 (1.7)	10.0 (3.7)	11.1 (2.8)	13.1 (4.6)	15.7 (3.0)
BQ-123 20 min	17.4 (3.3)	6.0 (3.3)	18.0 (4.7)	18.7 (3.2)	20.4 (3.1)	14.7 (3.9)
BQ-123 30 min	22.3 (5.1)	-1.1 (3.3)	23.0 (4.6)	21.1 (4.8)	26.8 (5.1)	23.3 (4.5)
BQ-123 40 min	25.6 (6.3)	3.8 (3.2)	28.4 (4.9)	28.9 (3.8)	23.9 (4.3)	25.7 (3.9)
BQ-123 50 min	25.8 (4.6)	6.1 (3.6)	31.4 (5.9)	27.7 (4.8)	29.0 (5.6)	26.5 (4.5)
BQ-123 60 min	27.0 (6.4)	1.1 (4.5)	34.4 (5.7)	30.6 (5.5)	33.8 (5.3)	30.4 (3.7)
BQ-123+BQ-788 70 min	44.0 (6.9)	9.2 (3.7)	33.2 (6.9)	37.8 (5.7)	37.5 (8.3)	38.0 (7.5)
BQ-123+BQ-788 80 min	41.3 (7.0)	16.1 (8.2)	44.7 (7.3)	32.2 (7.3)	42.6 (9.5)	45.0 (7.9)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebivolol	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Metoprolol	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Placebo	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27113048Diehl 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher A DeSouza, Ph.D. principal investigator

University of Colorado at Boulder

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (time frame: Systolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01395329, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.