Trial Outcomes & Findings for 24 Hour Ambulatory Cardiac Oxygen Consumption (NCT NCT05170061)
NCT ID: NCT05170061
Last Updated: 2025-06-08
Results Overview
ACRPP is the product of estimated aortic mean systolic pressure (mean aortic pressure estimated using a transfer function applied to brachial cuff blood pressure) during the systolic time interval adjusted for heart rate. Units are (mmHg\*beats/min).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
measurement after 4 weeks in each treatment arm
Results posted on
2025-06-08
Participant Flow
Subjects were recruited from the practice of the investigator and by advertisement
Males and females, 18 years or older with chronic hypertension, treated or untreated, were eligible if their seated mean clinic systolic BP was 145-179 mm Hg, inclusive, or clinic diastolic BP 92-119 mm Hg, inclusive. Prior antihypertensive drug therapy was discontinued prior to randomization.
Participant milestones
| Measure |
Sequence 1: Nebivolol, Valsartan, Combination Nebivolol/Valsartan
Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week); Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week), then Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week).
|
Sequence 2: Nebivolol, Combination Nebivolol/Valsartan, Valsartan
Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week); Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week); Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week)
|
Sequence 3: Valsartan, Nebivolol, Combination Nebivolol/Valsartan
Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week); Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week), Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week).
|
Sequence 4: Valsartan, Combination Nebivolol/Valsartan, Nebivolol
Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week); Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week); Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week),
|
Sequence 5: Combination Nebivolol/Valsartan, Nebivolol, Valsartan
Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week); Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week); Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week);
|
Sequence 6: Combination Nebivolol/Valsartan, Valsartan, Nebivolol
Combination nebivolol/valsartan (20/160 mg daily for 1 week, then 40/320 mg daily for 3 weeks, then 20/160 mg daily for 1 week); Valsartan (160 mg daily for 1 week, then 320 mg daily for 3 weeks, then 160 mg daily for 1 week); Nebivolol (20 mg daily for 1 week, then 40 mg daily for 3 weeks, then 20 mg daily for 1 week),
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
5
|
5
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
24 Hour Ambulatory Cardiac Oxygen Consumption
Baseline characteristics by cohort
| Measure |
Sequence 1: Nebivolol, Valsartan, Nebivolol/Valsartan
n=5 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
Sequence 2: Nebivolol, Nebivolol/Valsartan, Valsartan
n=5 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Sequence 3: Valsartan, Nebivolol, Nebivolol/Valsartan
n=4 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
Sequence 4: Valsartan, Nebivolol/Valsartan, Nebivolol
n=4 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Sequence 5: Nebivolol/Valsartan, Nebivolol, Valsartan
n=4 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Sequence 6: Nebivolol/Valsartan, Valsartan, Nebivolol
n=4 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily; then Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily; then Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 10 • n=5 Participants
|
56 years
STANDARD_DEVIATION 9 • n=7 Participants
|
59 years
STANDARD_DEVIATION 10 • n=5 Participants
|
57 years
STANDARD_DEVIATION 9 • n=4 Participants
|
56 years
STANDARD_DEVIATION 11 • n=21 Participants
|
59 years
STANDARD_DEVIATION 11 • n=10 Participants
|
58 years
STANDARD_DEVIATION 10 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
4 participants
n=10 Participants
|
26 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: measurement after 4 weeks in each treatment armPopulation: Each group represents total number who received that treatment arm (n=26) given randomly in 6 possible sequences: N-V-N/V, N-N/V-V, V-N-N/V, V-N/V-N, N/V-N-V, N/V-V-N) Design was used to minimize any potential carryover bias from prior treatment, in part because of the relatively short duration of each treatment and the absence of washout periods between arms.
ACRPP is the product of estimated aortic mean systolic pressure (mean aortic pressure estimated using a transfer function applied to brachial cuff blood pressure) during the systolic time interval adjusted for heart rate. Units are (mmHg\*beats/min).
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI)
|
2531 mmHg*beats/min
Standard Deviation 400
|
2824 mmHg*beats/min
Standard Deviation 530
|
2484 mmHg*beats/min
Standard Deviation 368
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armSeated office cuff systolic blood pressure (mmHg)
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Cuff SBP
|
150 mmHg
Standard Deviation 17
|
148 mmHg
Standard Deviation 17
|
146 mmHg
Standard Deviation 20
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Seated office cuff diastolic blood pressure (mmHg)
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Cuff DBP
|
84 mmHg
Standard Deviation 12
|
87 mmHg
Standard Deviation 13
|
81 mmHg
Standard Deviation 12
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
24-hour mean heart rate x 24-hour mean systolic BP
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Ambulatory Brachial Double Product
|
9329 mmHg*beats/min
Standard Deviation 1572
|
11239 mmHg*beats/min
Standard Deviation 2336
|
9154 mmHg*beats/min
Standard Deviation 1607
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Mean heart rate over 24 hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Ambulatory Mean Heart Rate
|
64 beats/min
Standard Deviation 8
|
77 beats/min
Standard Deviation 16
|
63 beats/min
Standard Deviation 10
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Mean ambulatory aortic (central) diastolic pressure over 24 hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Ambulatory Mean Central Diastolic BP
|
91 mmHg
Standard Deviation 13
|
90 mmHg
Standard Deviation 12
|
89 mmHg
Standard Deviation 13
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: all participants
Mean 24-hour ambulatory systolic BP
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
24-hour Brachial Systolic BP
|
147 mmHg
Standard Deviation 15
|
143 mmHg
Standard Deviation 16
|
145 mmHg
Standard Deviation 16
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Mean 24-hour ambulatory cuff diastolic BP
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
24-hour Brachial Diastolic BP
|
89 mmHg
Standard Deviation 12
|
88 mmHg
Standard Deviation 12
|
87 mmHg
Standard Deviation 13
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Determined by ambulatory heart rate-central systolic pressure product during self-reported waking hours at the end of each study phase
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI)
|
2482 mmHg*beats/min
Standard Deviation 368
|
2817 mmHg*beats/min
Standard Deviation 394
|
2423 mmHg*beats/min
Standard Deviation 390
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Determined by ambulatory heart rate-central systolic pressure product during self-reported sleeping hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Nighttime ACRPP
|
2454 mmHg*beats/min
Standard Deviation 471
|
2564 mmHg*beats/min
Standard Deviation 516
|
2309 mmHg*beats/min
Standard Deviation 446
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Mean ambulatory heart rate during self-reported waking hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Daytime Heart Rate
|
64 beats/min
Standard Deviation 10
|
81 beats/min
Standard Deviation 13
|
64 beats/min
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: all participants
Mean ambulatory heart rate during self-reported sleeping hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Nighttime Heart Rate
|
64 beats/min
Standard Deviation 9
|
74 beats/min
Standard Deviation 12
|
63 beats/min
Standard Deviation 10
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Mean ambulatory central systolic pressure during self-reported waking hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Daytime Central Systolic Pressure
|
138 mmHg
Standard Deviation 11
|
135 mmHg
Standard Deviation 14
|
136 mmHg
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: all participants
Mean ambulatory central systolic pressure during self-reported sleeping hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Nighttime Central Systolic Pressure
|
135 mmHg
Standard Deviation 20
|
130 mmHg
Standard Deviation 19
|
131 mmHg
Standard Deviation 16
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Mean ambulatory brachial systolic pressure during self-reported waking hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Daytime Brachial Systolic Pressure
|
149 mmHg
Standard Deviation 12
|
146 mmHg
Standard Deviation 15
|
147 mmHg
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: all participants
Mean ambulatory brachial systolic pressure during self-reported sleeping hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Nighttime Brachial Systolic Pressure
|
145 mmHg
Standard Deviation 21
|
138 mmHg
Standard Deviation 19
|
141 mmHg
Standard Deviation 17
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: all participants
Mean ambulatory central diastolic pressure during self-reported waking hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Daytime Central Diastolic Pressure
|
93 mmHg
Standard Deviation 11
|
93 mmHg
Standard Deviation 12
|
92 mmHg
Standard Deviation 13
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Mean ambulatory central diastolic pressure during self-reported sleeping hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Nighttime Central Diastolic Pressure
|
89 mmHg
Standard Deviation 15
|
86 mmHg
Standard Deviation 15
|
85 mmHg
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: all participants
Mean ambulatory brachial diastolic pressure during self-reported waking hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Daytime Brachial Diastolic Pressure
|
91 mmHg
Standard Deviation 10
|
91 mmHg
Standard Deviation 11
|
89 mmHg
Standard Deviation 13
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Mean ambulatory brachial diastolic pressure during self-reported sleeping hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Nighttime Brachial Diastolic Pressure
|
87 mmHg
Standard Deviation 16
|
83 mmHg
Standard Deviation 14
|
83 mmHg
Standard Deviation 14
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported waking hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Ambulatory Daytime Brachial Rate-pressure Product
|
9528 mmHg*beats/min
Standard Deviation 1530
|
11869 mmHg*beats/min
Standard Deviation 2265
|
9335 mmHg*beats/min
Standard Deviation 1607
|
SECONDARY outcome
Timeframe: After 4 weeks in each treatment armPopulation: all participants
Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported sleeping hours
Outcome measures
| Measure |
Nebivolol
n=26 Participants
Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily
|
Valsartan
n=26 Participants
Valsartan, 160 mg daily for 1 week followed by 320 mg daily for 3 weeks, followed by 1-week down-titration to 160 mg daily
|
Nebivolol/Valsartan
n=26 Participants
Combination of nebivolol/valsartan 20/160 mg daily for 1 week followed by 40/320 mg daily for 3 weeks, followed by 1-week down-titration to 20/160 mg daily
|
|---|---|---|---|
|
Ambulatory Nighttime Brachial Rate-pressure Product
|
9284 mmHg*beats/min
Standard Deviation 1920
|
10338 mmHg*beats/min
Standard Deviation 2449
|
8830 mmHg*beats/min
Standard Deviation 1827
|
Adverse Events
Nebivolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Valsartan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nebivolol/Valsartan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place