Trial Outcomes & Findings for Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension (NCT NCT01202175)
NCT ID: NCT01202175
Last Updated: 2019-08-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Basline (visit 1) and 8 weeks (visit 2)
Results posted on
2019-08-21
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
Nebivolol
|
25
|
|
Overall Study
Pacebo
|
25
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension
Baseline characteristics by cohort
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.1 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
33.7 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Body Mass Index
|
28.55 kg/m^2
STANDARD_DEVIATION 0.92 • n=5 Participants
|
31.03 kg/m^2
STANDARD_DEVIATION 1.14 • n=7 Participants
|
29.79 kg/m^2
STANDARD_DEVIATION .86 • n=5 Participants
|
|
Starting systolic blood pressure
|
127.4 mm Hg
STANDARD_DEVIATION 1.6 • n=5 Participants
|
126.2 mm Hg
STANDARD_DEVIATION 1.5 • n=7 Participants
|
126.8 mm Hg
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Starting diastolic blood pressure
|
84.7 mm Hg
STANDARD_DEVIATION 1.5 • n=5 Participants
|
84.4 mm Hg
STANDARD_DEVIATION 1.0 • n=7 Participants
|
84.5 mm Hg
STANDARD_DEVIATION 0.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Aortic Systolic Blood Pressure (SBP)
Baseline (visit 1)
|
112.7 mm Hg
Standard Deviation 2.5
|
107.7 mm Hg
Standard Deviation 1.9
|
|
Aortic Systolic Blood Pressure (SBP)
Week 8 (visit 2)
|
106.2 mm Hg
Standard Deviation 2.4
|
106.6 mm Hg
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Aortic Diastolic Blood Pressure (DBP)
Baseline (visit 1)
|
79.1 mm Hg
Standard Deviation 2.3
|
75.9 mm Hg
Standard Deviation 1.7
|
|
Aortic Diastolic Blood Pressure (DBP)
Week 8 (visit 2)
|
71.3 mm Hg
Standard Deviation 1.9
|
74 mm Hg
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Aortic Mean Arterial Pressure (MAP)
Baseline (visit 1)
|
94.2 mm Hg
Standard Deviation 2.1
|
90.4 mm Hg
Standard Deviation 1.6
|
|
Aortic Mean Arterial Pressure (MAP)
Week 8 (visit 2)
|
86.8 mm Hg
Standard Deviation 1.9
|
88.6 mm Hg
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Aortic Pulse Pressure
Baseline (visit 1)
|
33.6 mm Hg
Standard Deviation 2.3
|
31.8 mm Hg
Standard Deviation 1.4
|
|
Aortic Pulse Pressure
Week 8 (visit 2)
|
34.9 mm Hg
Standard Deviation 1.8
|
32.6 mm Hg
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Aortic Augmentation Pressure
Baseline (visit 1)
|
7.4 mm Hg
Standard Deviation 2.0
|
5.5 mm Hg
Standard Deviation 1.0
|
|
Aortic Augmentation Pressure
Week 8 (visit 2)
|
6.8 mm Hg
Standard Deviation 1.6
|
5.3 mm Hg
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Aortic Augmentation Index for Heart Rate
Baseline (visit 1)
|
14.7 percentage
Standard Deviation 3.4
|
14.5 percentage
Standard Deviation 2.4
|
|
Aortic Augmentation Index for Heart Rate
Week 8 (visit 2)
|
11.9 percentage
Standard Deviation 3.8
|
12.8 percentage
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Pulse Wave Velocity
Baseline (visit 1)
|
6.73 m/s
Standard Deviation 0.28
|
5.95 m/s
Standard Deviation 0.19
|
|
Pulse Wave Velocity
Week 8 (visit 2)
|
6.00 m/s
Standard Deviation 0.18
|
5.78 m/s
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Heart Rate, Beats Per a Minute
Baseline (visit 1)
|
72.0 beats per a minute
Standard Deviation 1.9
|
75.6 beats per a minute
Standard Deviation 1.9
|
|
Heart Rate, Beats Per a Minute
Week 8 (visit 2)
|
64.4 beats per a minute
Standard Deviation 2.3
|
72.1 beats per a minute
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Urinary Nitric Oxide Excretion
Baseline (visit 1)
|
40.31 umol/ mg Cr
Standard Deviation 5.05
|
61.77 umol/ mg Cr
Standard Deviation 11.86
|
|
Urinary Nitric Oxide Excretion
Week 8 (visit 2)
|
64.38 umol/ mg Cr
Standard Deviation 14.25
|
65.54 umol/ mg Cr
Standard Deviation 10.54
|
SECONDARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Urinary Isoprostane Excretion
Baseline (visit 1)
|
180 pg/ mg Cr
Standard Deviation 14
|
165 pg/ mg Cr
Standard Deviation 17
|
|
Urinary Isoprostane Excretion
Week 8 (visit 2)
|
213 pg/ mg Cr
Standard Deviation 20
|
185 pg/ mg Cr
Standard Deviation 22
|
SECONDARY outcome
Timeframe: Baseline (visit 1) and 8 Weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Urinary Hydrogen Peroxide Excretion
Baseline (visit 1)
|
0.652 umol/ mg Cr
Standard Error 0.274
|
0.500 umol/ mg Cr
Standard Error 0.281
|
|
Urinary Hydrogen Peroxide Excretion
Week 8 (visit 2)
|
2.79 umol/ mg Cr
Standard Error 1.83
|
0.578 umol/ mg Cr
Standard Error 0.194
|
SECONDARY outcome
Timeframe: Basline (visit 1) and 8 weeks (visit 2)Outcome measures
| Measure |
Nebivolol
n=25 Participants
Nebivolol: Oral nebivolol 5 mg once daily
|
Placebo
n=25 Participants
|
|---|---|---|
|
Plasma Interleukin Levels
Baseline (visit 1)
|
1.626 pg/ mL
Standard Deviation 0.598
|
1.351 pg/ mL
Standard Deviation 0.258
|
|
Plasma Interleukin Levels
Week 8 (visit 2)
|
1.647 pg/ mL
Standard Deviation 0.689
|
1.351 pg/ mL
Standard Deviation 0.258
|
Adverse Events
All Study Particpants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Study Particpants
n=50 participants at risk
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.
|
|---|---|
|
Infections and infestations
Flue like symptoms
|
2.0%
1/50 • Number of events 50
|
Additional Information
Joachim H. Ix, MD, MAS
Univeristy of California, San Diego
Phone: 858-552-7528
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place