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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Nebivolol first, then valsartan, then combination of nebivolol/valsartan | Active Comparator | 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 first, then combination of nebivolol/valsartan; then valsartan | Active Comparator | 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 first, then Nebivolol, then combination of nebivolol/valsartan, | Active Comparator | 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; |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | Nebivolol 20 mg daily (1 week) followed by nebivolol 40 mg daily (3 weeks) followed by nebivolol 20 mg daily (1 week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | measurement after 4 weeks in each treatment arm |
| Measure | Description | Time Frame |
|---|---|---|
| Cuff SBP | Seated office cuff systolic blood pressure (mmHg) | After 4 weeks in each treatment arm |
| Cuff DBP | Seated office cuff diastolic blood pressure (mmHg) |
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Inclusion Criteria:
Subjects with chronic hypertension, treated or untreated
Exclusion Criteria:
Subjects with any of the following conditions will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph L Izzo, MD | SUNY Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26116459 | Result | Izzo JL Jr, Khan SU, Saleem O, Osmond PJ. Ambulatory 24-hour cardiac oxygen consumption and blood pressure-heart rate variability: effects of nebivolol and valsartan alone and in combination. J Am Soc Hypertens. 2015 Jul;9(7):526-35. doi: 10.1016/j.jash.2015.03.009. Epub 2015 Mar 28. |
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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.
Subjects were recruited from the practice of the investigator and by advertisement
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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) |
| FG002 | 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). |
| FG003 | 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), |
| FG004 | 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); |
| FG005 | 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), |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Mean | Standard Deviation | mmHg*beats/min | measurement after 4 weeks in each treatment arm |
|
15 weeks for each participant; approximately 1-year for the study overall
same definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nebivolol | Nebivolol, 20 mg daily for 1 week followed by 40 mg daily for 3 weeks, followed by 1 week down-titration to 20 mg daily |
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Relatively small sample size limits extrapolation. Small number of non-blacks precludes racial stratification.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Izzo MD | SUNYBuffalo | 7168985625 | jizzo@buffalo.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Random-order-entry 3-way crossover of active treatments; all participants receive all 3 active treatments with 6 possible experimental sequences (arms)
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Double-blinded: drugs formulated into capsules by an outside research pharmacist who held the codes until study completion
| Sequence 4: Valsartan first, then combination of nebivolol/valsartan, then Nebivolol, | Active Comparator | 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: Combination of nebivolol/valsartan first, then Nebivolol, then Valsartan, | Active Comparator | 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: Combination of nebivolol/valsartan first, then Valsartan, then Nebivolol, , | Active Comparator | 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; then |
|
|
| Valsartan | Drug | Valsartan 160 mg daily (1 week) followed by valsartan 320 mg daily (3 weeks) followed by valsartan 160 mg daily (1 week). |
|
|
| Nebivolol/valsartan combination | Drug | 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) |
|
|
| After 4 weeks in each treatment arm |
| Ambulatory Brachial Double Product | 24-hour mean heart rate x 24-hour mean systolic BP | After 4 weeks in each treatment arm |
| Ambulatory Mean Heart Rate | Mean heart rate over 24 hours | After 4 weeks in each treatment arm |
| Ambulatory Mean Central Diastolic BP | Mean ambulatory aortic (central) diastolic pressure over 24 hours | After 4 weeks in each treatment arm |
| 24-hour Brachial Systolic BP | Mean 24-hour ambulatory systolic BP | 4 weeks |
| 24-hour Brachial Diastolic BP | Mean 24-hour ambulatory cuff diastolic BP | After 4 weeks in each treatment arm |
| 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 | After 4 weeks in each treatment arm |
| Nighttime ACRPP | Determined by ambulatory heart rate-central systolic pressure product during self-reported sleeping hours | After 4 weeks in each treatment arm |
| Daytime Heart Rate | Mean ambulatory heart rate during self-reported waking hours | After 4 weeks in each treatment arm |
| Nighttime Heart Rate | Mean ambulatory heart rate during self-reported sleeping hours | 4 weeks |
| Daytime Central Systolic Pressure | Mean ambulatory central systolic pressure during self-reported waking hours | After 4 weeks in each treatment arm |
| Nighttime Central Systolic Pressure | Mean ambulatory central systolic pressure during self-reported sleeping hours | 4 weeks |
| Daytime Brachial Systolic Pressure | Mean ambulatory brachial systolic pressure during self-reported waking hours | After 4 weeks in each treatment arm |
| Nighttime Brachial Systolic Pressure | Mean ambulatory brachial systolic pressure during self-reported sleeping hours | 4 weeks |
| Daytime Central Diastolic Pressure | Mean ambulatory central diastolic pressure during self-reported waking hours | 4 weeks |
| Nighttime Central Diastolic Pressure | Mean ambulatory central diastolic pressure during self-reported sleeping hours | After 4 weeks in each treatment arm |
| Daytime Brachial Diastolic Pressure | Mean ambulatory brachial diastolic pressure during self-reported waking hours | 4 weeks |
| Nighttime Brachial Diastolic Pressure | Mean ambulatory brachial diastolic pressure during self-reported sleeping hours | After 4 weeks in each treatment arm |
| Ambulatory Daytime Brachial Rate-pressure Product | Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported waking hours | After 4 weeks in each treatment arm |
| Ambulatory Nighttime Brachial Rate-pressure Product | Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported sleeping hours | After 4 weeks in each treatment arm |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | 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 |
| BG005 | 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 |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
| OG002 | 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 |
|
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| Secondary | Cuff SBP | Seated office cuff systolic blood pressure (mmHg) | Posted | Mean | Standard Deviation | mmHg | After 4 weeks in each treatment arm |
|
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| Secondary | Cuff DBP | Seated office cuff diastolic blood pressure (mmHg) | all participants | Posted | Mean | Standard Deviation | mmHg | After 4 weeks in each treatment arm |
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| Secondary | Ambulatory Brachial Double Product | 24-hour mean heart rate x 24-hour mean systolic BP | all participants | Posted | Mean | Standard Deviation | mmHg*beats/min | After 4 weeks in each treatment arm |
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| Secondary | Ambulatory Mean Heart Rate | Mean heart rate over 24 hours | all participants | Posted | Mean | Standard Deviation | beats/min | After 4 weeks in each treatment arm |
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| Secondary | Ambulatory Mean Central Diastolic BP | Mean ambulatory aortic (central) diastolic pressure over 24 hours | all participants | Posted | Mean | Standard Deviation | mmHg | After 4 weeks in each treatment arm |
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| Secondary | 24-hour Brachial Systolic BP | Mean 24-hour ambulatory systolic BP | all participants | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
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| Secondary | 24-hour Brachial Diastolic BP | Mean 24-hour ambulatory cuff diastolic BP | all participants | Posted | Mean | Standard Deviation | mmHg | After 4 weeks in each treatment arm |
|
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|
|
| 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 | all participants | Posted | Mean | Standard Deviation | mmHg*beats/min | After 4 weeks in each treatment arm |
|
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|
|
| Secondary | Nighttime ACRPP | Determined by ambulatory heart rate-central systolic pressure product during self-reported sleeping hours | all participants | Posted | Mean | Standard Deviation | mmHg*beats/min | After 4 weeks in each treatment arm |
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| Secondary | Daytime Heart Rate | Mean ambulatory heart rate during self-reported waking hours | all participants | Posted | Mean | Standard Deviation | beats/min | After 4 weeks in each treatment arm |
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| Secondary | Nighttime Heart Rate | Mean ambulatory heart rate during self-reported sleeping hours | all participants | Posted | Mean | Standard Deviation | beats/min | 4 weeks |
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| Secondary | Daytime Central Systolic Pressure | Mean ambulatory central systolic pressure during self-reported waking hours | all participants | Posted | Mean | Standard Deviation | mmHg | After 4 weeks in each treatment arm |
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| Secondary | Nighttime Central Systolic Pressure | Mean ambulatory central systolic pressure during self-reported sleeping hours | all participants | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
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| Secondary | Daytime Brachial Systolic Pressure | Mean ambulatory brachial systolic pressure during self-reported waking hours | all participants | Posted | Mean | Standard Deviation | mmHg | After 4 weeks in each treatment arm |
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| Secondary | Nighttime Brachial Systolic Pressure | Mean ambulatory brachial systolic pressure during self-reported sleeping hours | all participants | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
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| Secondary | Daytime Central Diastolic Pressure | Mean ambulatory central diastolic pressure during self-reported waking hours | all participants | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
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| Secondary | Nighttime Central Diastolic Pressure | Mean ambulatory central diastolic pressure during self-reported sleeping hours | all participants | Posted | Mean | Standard Deviation | mmHg | After 4 weeks in each treatment arm |
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| Secondary | Daytime Brachial Diastolic Pressure | Mean ambulatory brachial diastolic pressure during self-reported waking hours | all participants | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
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| Secondary | Nighttime Brachial Diastolic Pressure | Mean ambulatory brachial diastolic pressure during self-reported sleeping hours | all participants | Posted | Mean | Standard Deviation | mmHg | After 4 weeks in each treatment arm |
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| Secondary | Ambulatory Daytime Brachial Rate-pressure Product | Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported waking hours | all participants | Posted | Mean | Standard Deviation | mmHg*beats/min | After 4 weeks in each treatment arm |
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| Secondary | Ambulatory Nighttime Brachial Rate-pressure Product | Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported sleeping hours | all participants | Posted | Mean | Standard Deviation | mmHg*beats/min | After 4 weeks in each treatment arm |
|
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|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 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 | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | 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 | 0 | 26 | 0 | 26 | 0 | 26 |
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| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |