Hypertension
Conditions
Keywords
Myocardial oxygen consumption, Systolic blood pressure, Diastolic blood pressure, Variability in hemodynamic indicators, Valsartan, Nebivolol, IEM ambulatory monitoring
Brief summary
A randomized,double-blind, active controlled,15 week study to evaluate the effects of nebivolol and valsartan alone and in combination on 24-hour ambulatory cardiac work and variability of heart rate-mean central systolic pressure product.
Detailed description
Subjects with hypertension (systolic blood pressure (SBP) \>140 or diastolic blood pressure (DBP)\>90, n=26) were studied using a double-blinded, forced-titration, sequence-controlled, crossover design with 3 experimental periods: Valsartan 320, nebivolol 40, and nebivolol/valsartan 320/40 mg daily. After 4 weeks of each drug, ambulatory pulse wave analysis (IEM MobilOGraph) was performed every 20 min for 24-hours. The primary hypothesis was that nebivolol/valsartan combination therapy would be superior to valsartan monotherapy in reducing mean 24-hour mean myocardial oxygen consumption determined by 24-hour ambulatory heart rate-central systolic pressure product \[ACRPP\]. A secondary hypothesis was that the combination would also reduce the variability of 24-hour myocardial oxygen consumption.
Interventions
DRUGNebivolol
Nebivolol 20 mg daily (1 week) followed by nebivolol 40 mg daily (3 weeks) followed by nebivolol 20 mg daily (1 week)
DRUGValsartan
Valsartan 160 mg daily (1 week) followed by valsartan 320 mg daily (3 weeks) followed by valsartan 160 mg daily (1 week).
DRUGNebivolol/valsartan combination
Valsartan/Nebivolol, 160/20 mg daily (1 week) followed by valsartan/nebivolol 320/40 mg daily (3 weeks) followed by valsartan/nebivolol 160/20 mg daily (1 week)
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blinded: drugs formulated into capsules by an outside research pharmacist who held the codes until study completion
Intervention model description
Random-order-entry 3-way crossover of active treatments; all participants receive all 3 active treatments with 6 possible experimental sequences (arms)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with chronic hypertension, treated or untreated * Males and females, 18 years or older * Seated clinic systolic BP 145-184 mmHg inclusive or * Seated clinic diastolic BP 92-119 mmHg, inclusive.
Exclusion criteria
* Subjects with any of the following conditions will be excluded: * Any acute or chronic medical condition that, in the judgment of the investigator, renders the subject unable to complete the study, would interfere with optimal participation in the study, or cause significant risk to the subject * Concomitant or probable need for treatment with other cardiovascular or antihypertensive drugs that may affect blood pressure or influence the effects of study drugs, (e.g. NSAIDs, beta-agonist inhalers therapy for bronchospastic asthma, diuretics); other stable chronic medications that have little effect on study drugs (e.g. diabetes medications, hormone replacements, chronic pain medications. osteoporosis drugs, vitamins, cholesterol drugs, etc.) are permitted if continued at stable doses throughout study. * History of clinically significant adverse events with beta-blocker or angiotensin-receptor blocker * Known or suspected secondary hypertension (e.g., renovascular hypertension, primary hyperaldosteronism, etc.) * Known ischemic heart disease requiring continuous beta-blocker therapy (includes angina, prior transmural myocardial infarction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty or stenting within 6 months prior to study entry). * Dilated cardiomyopathy (NYHA Functional Class III-IV) * Clinically significant valvular heart disease or obstructive hypertrophic cardiomyopathy * Presence of clinically significant ventricular or supraventricular arrhythmias (e.g. atrial fibrillation/flutter), pre-excitation syndrome, second or third degree atrioventricular block, other conduction defects necessitating the implantation of a permanent cardiac pacemaker, or sick sinus syndrome. * Chronic kidney disease (serum creatinine \>2.5 mg/dL) * Uncontrolled diabetes mellitus (hemoglobin A1c \> 10%) * History of alcohol or other drug abuse within 6 months prior to enrollment * Positive pregnancy test or failure to practice adequate contraception in women of child-bearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI) | measurement after 4 weeks in each treatment arm | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour Brachial Diastolic BP | After 4 weeks in each treatment arm | Mean 24-hour ambulatory cuff diastolic BP |
| Cuff SBP | After 4 weeks in each treatment arm | Seated office cuff systolic blood pressure (mmHg) |
| Cuff DBP | After 4 weeks in each treatment arm | Seated office cuff diastolic blood pressure (mmHg) |
| Ambulatory Brachial Double Product | After 4 weeks in each treatment arm | 24-hour mean heart rate x 24-hour mean systolic BP |
| Ambulatory Mean Heart Rate | After 4 weeks in each treatment arm | Mean heart rate over 24 hours |
| Ambulatory Mean Central Diastolic BP | After 4 weeks in each treatment arm | Mean ambulatory aortic (central) diastolic pressure over 24 hours |
| Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI) | After 4 weeks in each treatment arm | Determined by ambulatory heart rate-central systolic pressure product during self-reported waking hours at the end of each study phase |
| Nighttime ACRPP | After 4 weeks in each treatment arm | Determined by ambulatory heart rate-central systolic pressure product during self-reported sleeping hours |
| Daytime Heart Rate | After 4 weeks in each treatment arm | Mean ambulatory heart rate during self-reported waking hours |
| Nighttime Heart Rate | 4 weeks | Mean ambulatory heart rate during self-reported sleeping hours |
| 24-hour Brachial Systolic BP | 4 weeks | Mean 24-hour ambulatory systolic BP |
| Nighttime Central Systolic Pressure | 4 weeks | Mean ambulatory central systolic pressure during self-reported sleeping hours |
| Daytime Brachial Systolic Pressure | After 4 weeks in each treatment arm | Mean ambulatory brachial systolic pressure during self-reported waking hours |
| Nighttime Brachial Systolic Pressure | 4 weeks | Mean ambulatory brachial systolic pressure during self-reported sleeping hours |
| Daytime Central Diastolic Pressure | 4 weeks | Mean ambulatory central diastolic pressure during self-reported waking hours |
| Nighttime Central Diastolic Pressure | After 4 weeks in each treatment arm | Mean ambulatory central diastolic pressure during self-reported sleeping hours |
| Daytime Brachial Diastolic Pressure | 4 weeks | Mean ambulatory brachial diastolic pressure during self-reported waking hours |
| Nighttime Brachial Diastolic Pressure | After 4 weeks in each treatment arm | Mean ambulatory brachial diastolic pressure during self-reported sleeping hours |
| Ambulatory Daytime Brachial Rate-pressure Product | After 4 weeks in each treatment arm | Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported waking hours |
| Ambulatory Nighttime Brachial Rate-pressure Product | After 4 weeks in each treatment arm | Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported sleeping hours |
| Daytime Central Systolic Pressure | After 4 weeks in each treatment arm | Mean ambulatory central systolic pressure during self-reported waking hours |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the practice of the investigator and by advertisement
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1: Nebivolol, Valsartan, Nebivolol/Valsartan 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 | 5 |
| Sequence 2: Nebivolol, Nebivolol/Valsartan, Valsartan 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 | 5 |
| Sequence 3: Valsartan, Nebivolol, Nebivolol/Valsartan 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 | 4 |
| Sequence 4: Valsartan, Nebivolol/Valsartan, Nebivolol 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 | 4 |
| Sequence 5: Nebivolol/Valsartan, Nebivolol, Valsartan 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 | 4 |
| Sequence 6: Nebivolol/Valsartan, Valsartan, Nebivolol 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 | 4 |
| Total | 26 |
Baseline characteristics
| Characteristic | Sequence 2: Nebivolol, Nebivolol/Valsartan, Valsartan | Sequence 3: Valsartan, Nebivolol, Nebivolol/Valsartan | Sequence 4: Valsartan, Nebivolol/Valsartan, Nebivolol | Sequence 5: Nebivolol/Valsartan, Nebivolol, Valsartan | Sequence 6: Nebivolol/Valsartan, Valsartan, Nebivolol | Sequence 1: Nebivolol, Valsartan, Nebivolol/Valsartan | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 21 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 9 | 59 years STANDARD_DEVIATION 10 | 57 years STANDARD_DEVIATION 9 | 56 years STANDARD_DEVIATION 11 | 59 years STANDARD_DEVIATION 11 | 58 years STANDARD_DEVIATION 10 | 58 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 5 participants | 4 participants | 4 participants | 4 participants | 4 participants | 5 participants | 26 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 17 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 | 0 / 26 |
Outcome results
Primary
ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI)
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).
Time frame: measurement after 4 weeks in each treatment arm
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI) | 2531 mmHg*beats/min | Standard Deviation 400 |
| Valsartan | ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI) | 2824 mmHg*beats/min | Standard Deviation 530 |
| Nebivolol/Valsartan | ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI) | 2484 mmHg*beats/min | Standard Deviation 368 |
Comparison: Sequential analysis: if the first analysis (paired t-test to determine superiority of nebivolol/valsartan over valsartan ) reached p\< 0.05, the superiority of nebivolol over valsartan was tested (paired-t test); if the second comparison reached p \< 0.05, the superiority of nebivolol/valsartan over nebivolol was tested (paired-t test)p-value: 0.05t-test, 2 sided
Secondary
24-hour Brachial Diastolic BP
Mean 24-hour ambulatory cuff diastolic BP
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | 24-hour Brachial Diastolic BP | 89 mmHg | Standard Deviation 12 |
| Valsartan | 24-hour Brachial Diastolic BP | 88 mmHg | Standard Deviation 12 |
| Nebivolol/Valsartan | 24-hour Brachial Diastolic BP | 87 mmHg | Standard Deviation 13 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
24-hour Brachial Systolic BP
Mean 24-hour ambulatory systolic BP
Time frame: 4 weeks
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | 24-hour Brachial Systolic BP | 147 mmHg | Standard Deviation 15 |
| Valsartan | 24-hour Brachial Systolic BP | 143 mmHg | Standard Deviation 16 |
| Nebivolol/Valsartan | 24-hour Brachial Systolic BP | 145 mmHg | Standard Deviation 16 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Ambulatory Brachial Double Product
24-hour mean heart rate x 24-hour mean systolic BP
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Ambulatory Brachial Double Product | 9329 mmHg*beats/min | Standard Deviation 1572 |
| Valsartan | Ambulatory Brachial Double Product | 11239 mmHg*beats/min | Standard Deviation 2336 |
| Nebivolol/Valsartan | Ambulatory Brachial Double Product | 9154 mmHg*beats/min | Standard Deviation 1607 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Ambulatory Daytime Brachial Rate-pressure Product
Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported waking hours
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Ambulatory Daytime Brachial Rate-pressure Product | 9528 mmHg*beats/min | Standard Deviation 1530 |
| Valsartan | Ambulatory Daytime Brachial Rate-pressure Product | 11869 mmHg*beats/min | Standard Deviation 2265 |
| Nebivolol/Valsartan | Ambulatory Daytime Brachial Rate-pressure Product | 9335 mmHg*beats/min | Standard Deviation 1607 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Ambulatory Mean Central Diastolic BP
Mean ambulatory aortic (central) diastolic pressure over 24 hours
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Ambulatory Mean Central Diastolic BP | 91 mmHg | Standard Deviation 13 |
| Valsartan | Ambulatory Mean Central Diastolic BP | 90 mmHg | Standard Deviation 12 |
| Nebivolol/Valsartan | Ambulatory Mean Central Diastolic BP | 89 mmHg | Standard Deviation 13 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Ambulatory Mean Heart Rate
Mean heart rate over 24 hours
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Ambulatory Mean Heart Rate | 64 beats/min | Standard Deviation 8 |
| Valsartan | Ambulatory Mean Heart Rate | 77 beats/min | Standard Deviation 16 |
| Nebivolol/Valsartan | Ambulatory Mean Heart Rate | 63 beats/min | Standard Deviation 10 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Ambulatory Nighttime Brachial Rate-pressure Product
Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported sleeping hours
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Ambulatory Nighttime Brachial Rate-pressure Product | 9284 mmHg*beats/min | Standard Deviation 1920 |
| Valsartan | Ambulatory Nighttime Brachial Rate-pressure Product | 10338 mmHg*beats/min | Standard Deviation 2449 |
| Nebivolol/Valsartan | Ambulatory Nighttime Brachial Rate-pressure Product | 8830 mmHg*beats/min | Standard Deviation 1827 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Cuff DBP
Seated office cuff diastolic blood pressure (mmHg)
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Cuff DBP | 84 mmHg | Standard Deviation 12 |
| Valsartan | Cuff DBP | 87 mmHg | Standard Deviation 13 |
| Nebivolol/Valsartan | Cuff DBP | 81 mmHg | Standard Deviation 12 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Cuff SBP
Seated office cuff systolic blood pressure (mmHg)
Time frame: After 4 weeks in each treatment arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Cuff SBP | 150 mmHg | Standard Deviation 17 |
| Valsartan | Cuff SBP | 148 mmHg | Standard Deviation 17 |
| Nebivolol/Valsartan | Cuff SBP | 146 mmHg | Standard Deviation 20 |
p-value: 0.05t-test, 2 sided
Secondary
Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI)
Determined by ambulatory heart rate-central systolic pressure product during self-reported waking hours at the end of each study phase
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI) | 2482 mmHg*beats/min | Standard Deviation 368 |
| Valsartan | Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI) | 2817 mmHg*beats/min | Standard Deviation 394 |
| Nebivolol/Valsartan | Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI) | 2423 mmHg*beats/min | Standard Deviation 390 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Daytime Brachial Diastolic Pressure
Mean ambulatory brachial diastolic pressure during self-reported waking hours
Time frame: 4 weeks
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Daytime Brachial Diastolic Pressure | 91 mmHg | Standard Deviation 10 |
| Valsartan | Daytime Brachial Diastolic Pressure | 91 mmHg | Standard Deviation 11 |
| Nebivolol/Valsartan | Daytime Brachial Diastolic Pressure | 89 mmHg | Standard Deviation 13 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Daytime Brachial Systolic Pressure
Mean ambulatory brachial systolic pressure during self-reported waking hours
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Daytime Brachial Systolic Pressure | 149 mmHg | Standard Deviation 12 |
| Valsartan | Daytime Brachial Systolic Pressure | 146 mmHg | Standard Deviation 15 |
| Nebivolol/Valsartan | Daytime Brachial Systolic Pressure | 147 mmHg | Standard Deviation 16 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Daytime Central Diastolic Pressure
Mean ambulatory central diastolic pressure during self-reported waking hours
Time frame: 4 weeks
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Daytime Central Diastolic Pressure | 93 mmHg | Standard Deviation 11 |
| Valsartan | Daytime Central Diastolic Pressure | 93 mmHg | Standard Deviation 12 |
| Nebivolol/Valsartan | Daytime Central Diastolic Pressure | 92 mmHg | Standard Deviation 13 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Daytime Central Systolic Pressure
Mean ambulatory central systolic pressure during self-reported waking hours
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Daytime Central Systolic Pressure | 138 mmHg | Standard Deviation 11 |
| Valsartan | Daytime Central Systolic Pressure | 135 mmHg | Standard Deviation 14 |
| Nebivolol/Valsartan | Daytime Central Systolic Pressure | 136 mmHg | Standard Deviation 14 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Daytime Heart Rate
Mean ambulatory heart rate during self-reported waking hours
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Daytime Heart Rate | 64 beats/min | Standard Deviation 10 |
| Valsartan | Daytime Heart Rate | 81 beats/min | Standard Deviation 13 |
| Nebivolol/Valsartan | Daytime Heart Rate | 64 beats/min | Standard Deviation 9 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Nighttime ACRPP
Determined by ambulatory heart rate-central systolic pressure product during self-reported sleeping hours
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Nighttime ACRPP | 2454 mmHg*beats/min | Standard Deviation 471 |
| Valsartan | Nighttime ACRPP | 2564 mmHg*beats/min | Standard Deviation 516 |
| Nebivolol/Valsartan | Nighttime ACRPP | 2309 mmHg*beats/min | Standard Deviation 446 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Nighttime Brachial Diastolic Pressure
Mean ambulatory brachial diastolic pressure during self-reported sleeping hours
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Nighttime Brachial Diastolic Pressure | 87 mmHg | Standard Deviation 16 |
| Valsartan | Nighttime Brachial Diastolic Pressure | 83 mmHg | Standard Deviation 14 |
| Nebivolol/Valsartan | Nighttime Brachial Diastolic Pressure | 83 mmHg | Standard Deviation 14 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Nighttime Brachial Systolic Pressure
Mean ambulatory brachial systolic pressure during self-reported sleeping hours
Time frame: 4 weeks
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Nighttime Brachial Systolic Pressure | 145 mmHg | Standard Deviation 21 |
| Valsartan | Nighttime Brachial Systolic Pressure | 138 mmHg | Standard Deviation 19 |
| Nebivolol/Valsartan | Nighttime Brachial Systolic Pressure | 141 mmHg | Standard Deviation 17 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Nighttime Central Diastolic Pressure
Mean ambulatory central diastolic pressure during self-reported sleeping hours
Time frame: After 4 weeks in each treatment arm
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Nighttime Central Diastolic Pressure | 89 mmHg | Standard Deviation 15 |
| Valsartan | Nighttime Central Diastolic Pressure | 86 mmHg | Standard Deviation 15 |
| Nebivolol/Valsartan | Nighttime Central Diastolic Pressure | 85 mmHg | Standard Deviation 14 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Nighttime Central Systolic Pressure
Mean ambulatory central systolic pressure during self-reported sleeping hours
Time frame: 4 weeks
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Nighttime Central Systolic Pressure | 135 mmHg | Standard Deviation 20 |
| Valsartan | Nighttime Central Systolic Pressure | 130 mmHg | Standard Deviation 19 |
| Nebivolol/Valsartan | Nighttime Central Systolic Pressure | 131 mmHg | Standard Deviation 16 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided
Secondary
Nighttime Heart Rate
Mean ambulatory heart rate during self-reported sleeping hours
Time frame: 4 weeks
Population: all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebivolol | Nighttime Heart Rate | 64 beats/min | Standard Deviation 9 |
| Valsartan | Nighttime Heart Rate | 74 beats/min | Standard Deviation 12 |
| Nebivolol/Valsartan | Nighttime Heart Rate | 63 beats/min | Standard Deviation 10 |
Comparison: see primary dependent variablep-value: 0.05t-test, 2 sided