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CompletedNCT05170061ACRPPUpdated Jun 8, 2025Results posted

24 Hour Ambulatory Cardiac Oxygen Consumption

A Phase 3 interventional study of Nebivolol and Valsartan in Hypertension, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.

Sponsored by State University of New York at Buffalo · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Myocardial oxygen consumption
  • Systolic blood pressure
  • Diastolic blood pressure
  • Variability in hemodynamic indicators
  • Valsartan
  • Nebivolol
  • IEM ambulatory monitoring
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 26 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Active comparator
    Sequence 1: Nebivolol first, then valsartan, then combination of 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

    Drug: Nebivolol · Drug: Valsartan · Drug: Nebivolol/valsartan combination

  • Active comparator
    Sequence 2: Nebivolol first, then combination of nebivolol/valsartan; then 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

    Drug: Nebivolol · Drug: Valsartan · Drug: Nebivolol/valsartan combination

  • Active comparator
    Sequence 3: Valsartan first, then Nebivolol, then combination of 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;

    Drug: Nebivolol · Drug: Valsartan · Drug: Nebivolol/valsartan combination

  • Active comparator
    Sequence 4: Valsartan first, then combination of nebivolol/valsartan, then 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;

    Drug: Nebivolol · Drug: Valsartan · Drug: Nebivolol/valsartan combination

  • Active comparator
    Sequence 5: Combination of nebivolol/valsartan first, then Nebivolol, then 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;

    Drug: Nebivolol · Drug: Valsartan · Drug: Nebivolol/valsartan combination

  • Active comparator
    Sequence 6: Combination of nebivolol/valsartan first, then Valsartan, then 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; then

    Drug: Nebivolol · Drug: Valsartan · Drug: Nebivolol/valsartan combination

Interventions

  • DrugNebivolol

    Nebivolol 20 mg daily (1 week) followed by nebivolol 40 mg daily (3 weeks) followed by nebivolol 20 mg daily (1 week)

    Also known as: Bystolic

  • DrugValsartan

    Valsartan 160 mg daily (1 week) followed by valsartan 320 mg daily (3 weeks) followed by valsartan 160 mg daily (1 week).

    Also known as: Diovan

  • 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)

    Also known as: Diovan/Bystolic

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Cuff SBP

    Seated office cuff systolic blood pressure (mmHg)

    Time frame: After 4 weeks in each treatment arm

  2. Cuff DBP

    Seated office cuff diastolic blood pressure (mmHg)

    Time frame: After 4 weeks in each treatment arm

  3. Ambulatory Brachial Double Product

    24-hour mean heart rate x 24-hour mean systolic BP

    Time frame: After 4 weeks in each treatment arm

  4. Ambulatory Mean Heart Rate

    Mean heart rate over 24 hours

    Time frame: After 4 weeks in each treatment arm

  5. Ambulatory Mean Central Diastolic BP

    Mean ambulatory aortic (central) diastolic pressure over 24 hours

    Time frame: After 4 weeks in each treatment arm

  6. 24-hour Brachial Systolic BP

    Mean 24-hour ambulatory systolic BP

    Time frame: 4 weeks

  7. 24-hour Brachial Diastolic BP

    Mean 24-hour ambulatory cuff diastolic BP

    Time frame: After 4 weeks in each treatment arm

  8. 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

  9. 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

  10. Daytime Heart Rate

    Mean ambulatory heart rate during self-reported waking hours

    Time frame: After 4 weeks in each treatment arm

  11. Nighttime Heart Rate

    Mean ambulatory heart rate during self-reported sleeping hours

    Time frame: 4 weeks

  12. Daytime Central Systolic Pressure

    Mean ambulatory central systolic pressure during self-reported waking hours

    Time frame: After 4 weeks in each treatment arm

  13. Nighttime Central Systolic Pressure

    Mean ambulatory central systolic pressure during self-reported sleeping hours

    Time frame: 4 weeks

  14. Daytime Brachial Systolic Pressure

    Mean ambulatory brachial systolic pressure during self-reported waking hours

    Time frame: After 4 weeks in each treatment arm

  15. Nighttime Brachial Systolic Pressure

    Mean ambulatory brachial systolic pressure during self-reported sleeping hours

    Time frame: 4 weeks

  16. Daytime Central Diastolic Pressure

    Mean ambulatory central diastolic pressure during self-reported waking hours

    Time frame: 4 weeks

  17. Nighttime Central Diastolic Pressure

    Mean ambulatory central diastolic pressure during self-reported sleeping hours

    Time frame: After 4 weeks in each treatment arm

  18. Daytime Brachial Diastolic Pressure

    Mean ambulatory brachial diastolic pressure during self-reported waking hours

    Time frame: 4 weeks

  19. Nighttime Brachial Diastolic Pressure

    Mean ambulatory brachial diastolic pressure during self-reported sleeping hours

    Time frame: After 4 weeks in each treatment arm

  20. 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

  21. 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

07

Results

Posted Jun 8, 2025
Limitations and caveats
Relatively small sample size limits extrapolation. Small number of non-blacks precludes racial stratification.

Participant flow

Subjects were recruited from the practice of the investigator and by advertisement

Participant flow — Overall Study
MilestoneSequence 1: Nebivolol, Valsartan, Combination Nebivolol/ValsartanSequence 2: Nebivolol, Combination Nebivolol/Valsartan, ValsartanSequence 3: Valsartan, Nebivolol, Combination Nebivolol/ValsartanSequence 4: Valsartan, Combination Nebivolol/Valsartan, NebivololSequence 5: Combination Nebivolol/Valsartan, Nebivolol, ValsartanSequence 6: Combination Nebivolol/Valsartan, Valsartan, Nebivolol
Started554444
Completed554444
Not completed000000

Outcome measures

PrimaryACRPP: 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
Reported as:
Mean · mmHg*beats/min
ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI)
mmHg*beats/minNebivololValsartanNebivolol/Valsartan
ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI)2531 ± 4002824 ± 5302484 ± 368
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05 (see above)paired analysis
SecondaryCuff SBP

Seated office cuff systolic blood pressure (mmHg)

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · mmHg
Cuff SBP
mmHgNebivololValsartanNebivolol/Valsartan
Cuff SBP150 ± 17148 ± 17146 ± 20
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryCuff DBP

Seated office cuff diastolic blood pressure (mmHg)

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · mmHg
Cuff DBP
mmHgNebivololValsartanNebivolol/Valsartan
Cuff DBP84 ± 1287 ± 1381 ± 12
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryAmbulatory Brachial Double Product

24-hour mean heart rate x 24-hour mean systolic BP

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · mmHg*beats/min
Ambulatory Brachial Double Product
mmHg*beats/minNebivololValsartanNebivolol/Valsartan
Ambulatory Brachial Double Product9329 ± 157211239 ± 23369154 ± 1607
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryAmbulatory Mean Heart Rate

Mean heart rate over 24 hours

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · beats/min
Ambulatory Mean Heart Rate
beats/minNebivololValsartanNebivolol/Valsartan
Ambulatory Mean Heart Rate64 ± 877 ± 1663 ± 10
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryAmbulatory Mean Central Diastolic BP

Mean ambulatory aortic (central) diastolic pressure over 24 hours

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · mmHg
Ambulatory Mean Central Diastolic BP
mmHgNebivololValsartanNebivolol/Valsartan
Ambulatory Mean Central Diastolic BP91 ± 1390 ± 1289 ± 13
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
Secondary24-hour Brachial Systolic BP

Mean 24-hour ambulatory systolic BP

Time frame:
4 weeks
Reported as:
Mean · mmHg
24-hour Brachial Systolic BP
mmHgNebivololValsartanNebivolol/Valsartan
24-hour Brachial Systolic BP147 ± 15143 ± 16145 ± 16
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
Secondary24-hour Brachial Diastolic BP

Mean 24-hour ambulatory cuff diastolic BP

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · mmHg
24-hour Brachial Diastolic BP
mmHgNebivololValsartanNebivolol/Valsartan
24-hour Brachial Diastolic BP89 ± 1288 ± 1287 ± 13
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryDaytime 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
Reported as:
Mean · mmHg*beats/min
Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI)
mmHg*beats/minNebivololValsartanNebivolol/Valsartan
Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI)2482 ± 3682817 ± 3942423 ± 390
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryNighttime ACRPP

Determined by ambulatory heart rate-central systolic pressure product during self-reported sleeping hours

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · mmHg*beats/min
Nighttime ACRPP
mmHg*beats/minNebivololValsartanNebivolol/Valsartan
Nighttime ACRPP2454 ± 4712564 ± 5162309 ± 446
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryDaytime Heart Rate

Mean ambulatory heart rate during self-reported waking hours

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · beats/min
Daytime Heart Rate
beats/minNebivololValsartanNebivolol/Valsartan
Daytime Heart Rate64 ± 1081 ± 1364 ± 9
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryNighttime Heart Rate

Mean ambulatory heart rate during self-reported sleeping hours

Time frame:
4 weeks
Reported as:
Mean · beats/min
Nighttime Heart Rate
beats/minNebivololValsartanNebivolol/Valsartan
Nighttime Heart Rate64 ± 974 ± 1263 ± 10
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryDaytime Central Systolic Pressure

Mean ambulatory central systolic pressure during self-reported waking hours

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · mmHg
Daytime Central Systolic Pressure
mmHgNebivololValsartanNebivolol/Valsartan
Daytime Central Systolic Pressure138 ± 11135 ± 14136 ± 14
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryNighttime Central Systolic Pressure

Mean ambulatory central systolic pressure during self-reported sleeping hours

Time frame:
4 weeks
Reported as:
Mean · mmHg
Nighttime Central Systolic Pressure
mmHgNebivololValsartanNebivolol/Valsartan
Nighttime Central Systolic Pressure135 ± 20130 ± 19131 ± 16
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryDaytime Brachial Systolic Pressure

Mean ambulatory brachial systolic pressure during self-reported waking hours

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · mmHg
Daytime Brachial Systolic Pressure
mmHgNebivololValsartanNebivolol/Valsartan
Daytime Brachial Systolic Pressure149 ± 12146 ± 15147 ± 16
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryNighttime Brachial Systolic Pressure

Mean ambulatory brachial systolic pressure during self-reported sleeping hours

Time frame:
4 weeks
Reported as:
Mean · mmHg
Nighttime Brachial Systolic Pressure
mmHgNebivololValsartanNebivolol/Valsartan
Nighttime Brachial Systolic Pressure145 ± 21138 ± 19141 ± 17
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryDaytime Central Diastolic Pressure

Mean ambulatory central diastolic pressure during self-reported waking hours

Time frame:
4 weeks
Reported as:
Mean · mmHg
Daytime Central Diastolic Pressure
mmHgNebivololValsartanNebivolol/Valsartan
Daytime Central Diastolic Pressure93 ± 1193 ± 1292 ± 13
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryNighttime Central Diastolic Pressure

Mean ambulatory central diastolic pressure during self-reported sleeping hours

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · mmHg
Nighttime Central Diastolic Pressure
mmHgNebivololValsartanNebivolol/Valsartan
Nighttime Central Diastolic Pressure89 ± 1586 ± 1585 ± 14
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryDaytime Brachial Diastolic Pressure

Mean ambulatory brachial diastolic pressure during self-reported waking hours

Time frame:
4 weeks
Reported as:
Mean · mmHg
Daytime Brachial Diastolic Pressure
mmHgNebivololValsartanNebivolol/Valsartan
Daytime Brachial Diastolic Pressure91 ± 1091 ± 1189 ± 13
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryNighttime Brachial Diastolic Pressure

Mean ambulatory brachial diastolic pressure during self-reported sleeping hours

Time frame:
After 4 weeks in each treatment arm
Reported as:
Mean · mmHg
Nighttime Brachial Diastolic Pressure
mmHgNebivololValsartanNebivolol/Valsartan
Nighttime Brachial Diastolic Pressure87 ± 1683 ± 1483 ± 14
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryAmbulatory 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
Reported as:
Mean · mmHg*beats/min
Ambulatory Daytime Brachial Rate-pressure Product
mmHg*beats/minNebivololValsartanNebivolol/Valsartan
Ambulatory Daytime Brachial Rate-pressure Product9528 ± 153011869 ± 22659335 ± 1607
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05
SecondaryAmbulatory 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
Reported as:
Mean · mmHg*beats/min
Ambulatory Nighttime Brachial Rate-pressure Product
mmHg*beats/minNebivololValsartanNebivolol/Valsartan
Ambulatory Nighttime Brachial Rate-pressure Product9284 ± 192010338 ± 24498830 ± 1827
Statistical analysis
  • Nebivolol vs Valsartan vs Nebivolol/Valsartan · t-test, 2 sided · p = 0.05

Adverse events

Collected over 15 weeks for each participant; approximately 1-year for the study overall. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nebivolol0/26 (0%)0/26 (0%)0/26 (0%)
Valsartan0/26 (0%)0/26 (0%)0/26 (0%)
Nebivolol/Valsartan0/26 (0%)0/26 (0%)0/26 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Sequence 1: Nebivolol, Valsartan, Nebivolol/ValsartanSequence 2: Nebivolol, Nebivolol/Valsartan, ValsartanSequence 3: Valsartan, Nebivolol, Nebivolol/ValsartanSequence 4: Valsartan, Nebivolol/Valsartan, NebivololSequence 5: Nebivolol/Valsartan, Nebivolol, ValsartanSequence 6: Nebivolol/Valsartan, Valsartan, NebivololTotal
<=18 years0000000
Between 18 and 65 years44433321
>=65 years1101115
Age, Continuous
Age, Continuous(years)Sequence 1: Nebivolol, Valsartan, Nebivolol/ValsartanSequence 2: Nebivolol, Nebivolol/Valsartan, ValsartanSequence 3: Valsartan, Nebivolol, Nebivolol/ValsartanSequence 4: Valsartan, Nebivolol/Valsartan, NebivololSequence 5: Nebivolol/Valsartan, Nebivolol, ValsartanSequence 6: Nebivolol/Valsartan, Valsartan, NebivololTotal
Mean58 ± 1056 ± 959 ± 1057 ± 956 ± 1159 ± 1158 ± 10
Sex: Female, Male
Sex: Female, Male(Participants)Sequence 1: Nebivolol, Valsartan, Nebivolol/ValsartanSequence 2: Nebivolol, Nebivolol/Valsartan, ValsartanSequence 3: Valsartan, Nebivolol, Nebivolol/ValsartanSequence 4: Valsartan, Nebivolol/Valsartan, NebivololSequence 5: Nebivolol/Valsartan, Nebivolol, ValsartanSequence 6: Nebivolol/Valsartan, Valsartan, NebivololTotal
Female43332217
Male1211229
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sequence 1: Nebivolol, Valsartan, Nebivolol/ValsartanSequence 2: Nebivolol, Nebivolol/Valsartan, ValsartanSequence 3: Valsartan, Nebivolol, Nebivolol/ValsartanSequence 4: Valsartan, Nebivolol/Valsartan, NebivololSequence 5: Nebivolol/Valsartan, Nebivolol, ValsartanSequence 6: Nebivolol/Valsartan, Valsartan, NebivololTotal
American Indian or Alaska Native0000000
Asian0000000
Native Hawaiian or Other Pacific Islander0000000
Black or African American44344423
White1110003
More than one race0000000
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(participants)Sequence 1: Nebivolol, Valsartan, Nebivolol/ValsartanSequence 2: Nebivolol, Nebivolol/Valsartan, ValsartanSequence 3: Valsartan, Nebivolol, Nebivolol/ValsartanSequence 4: Valsartan, Nebivolol/Valsartan, NebivololSequence 5: Nebivolol/Valsartan, Nebivolol, ValsartanSequence 6: Nebivolol/Valsartan, Valsartan, NebivololTotal
United States55444426
08

Study locations

1 site
  • Erie County Medical Center
    Buffalo, New York 14215, United States
09

References and documents

Publications

  • 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. PubMed 26116459 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05170061
Lead sponsor
State University of New York at Buffalo
Responsible party
JOSEPH IZZO (Principal Investigator, State University of New York at Buffalo) — Principal investigator
First posted
Dec 27, 2021
Start date
Feb 2013
Primary completion
Sep 2014
Completion
Dec 2014
Results posted
Jun 8, 2025
Last update
Jun 8, 2025

Study contacts

Joseph L Izzo, MD
principal investigator · SUNY Buffalo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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State University of New York at Buffalo

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