HypertensionPhase 3ACRPPNCT05170061

24 Hour Ambulatory Cardiac Oxygen Consumption

A Phase 3 study testing Nebivolol, Valsartan and Nebivolol/valsartan combination in people with Hypertension, run by State University of New York at Buffalo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Nebivolol, Valsartan and Nebivolol/valsartan combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Feb 2013to Dec 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Erie County Medical Center
Buffalo, New York, 14215

Other trials in United States

About this study

Official title: Ambulatory 24-Hour Cardiac Oxygen Consumption and Blood Pressure-Heart Rate Variability: Effects of Nebivolol and Valsartan Alone and in Combination

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.

Conditions: Hypertension
Being tested: Nebivolol, Valsartan, Nebivolol/valsartan combination
Keywords: Myocardial oxygen consumption, Systolic blood pressure, Diastolic blood pressure, Variability in hemodynamic indicators, Valsartan, Nebivolol, IEM ambulatory monitoring
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NebivololDrug
Also called Bystolic
Nebivolol 20 mg daily (1 week) followed by nebivolol 40 mg daily (3 weeks) followed by nebivolol 20 mg daily (1 week)
ValsartanDrug
Also called Diovan
Valsartan 160 mg daily (1 week) followed by valsartan 320 mg daily (3 weeks) followed by valsartan 160 mg daily (1 week).
Nebivolol/valsartan combinationDrug
Also called Diovan/Bystolic
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)

Study groups in NCT05170061
Study group	Role	What they receive
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 Receives: Drug: Nebivolol; Drug: Valsartan; Drug: Nebivolol/valsartan combination
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 Receives: Drug: Nebivolol; Drug: Valsartan; Drug: Nebivolol/valsartan combination
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; Receives: Drug: Nebivolol; Drug: Valsartan; Drug: Nebivolol/valsartan combination
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; Receives: Drug: Nebivolol; Drug: Valsartan; Drug: Nebivolol/valsartan combination
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; Receives: Drug: Nebivolol; Drug: Valsartan; Drug: Nebivolol/valsartan combination
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 Receives: Drug: Nebivolol; Drug: Valsartan; Drug: Nebivolol/valsartan combination

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: measurement after 4 weeks in each treatment arm

Secondary outcomes (21)

Cuff SBP
Seated office cuff systolic blood pressure (mmHg)
Measured: After 4 weeks in each treatment arm
Cuff DBP
Seated office cuff diastolic blood pressure (mmHg)
Measured: After 4 weeks in each treatment arm
Ambulatory Brachial Double Product
24-hour mean heart rate x 24-hour mean systolic BP
Measured: After 4 weeks in each treatment arm
Ambulatory Mean Heart Rate
Mean heart rate over 24 hours
Measured: After 4 weeks in each treatment arm
Ambulatory Mean Central Diastolic BP
Mean ambulatory aortic (central) diastolic pressure over 24 hours
Measured: After 4 weeks in each treatment arm
24-hour Brachial Systolic BP
Mean 24-hour ambulatory systolic BP
Measured: 4 weeks
24-hour Brachial Diastolic BP
Mean 24-hour ambulatory cuff diastolic BP
Measured: 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
Measured: After 4 weeks in each treatment arm
Nighttime ACRPP
Determined by ambulatory heart rate-central systolic pressure product during self-reported sleeping hours
Measured: After 4 weeks in each treatment arm
Daytime Heart Rate
Mean ambulatory heart rate during self-reported waking hours
Measured: After 4 weeks in each treatment arm
Nighttime Heart Rate
Mean ambulatory heart rate during self-reported sleeping hours
Measured: 4 weeks
Daytime Central Systolic Pressure
Mean ambulatory central systolic pressure during self-reported waking hours
Measured: After 4 weeks in each treatment arm
Nighttime Central Systolic Pressure
Mean ambulatory central systolic pressure during self-reported sleeping hours
Measured: 4 weeks
Daytime Brachial Systolic Pressure
Mean ambulatory brachial systolic pressure during self-reported waking hours
Measured: After 4 weeks in each treatment arm
Nighttime Brachial Systolic Pressure
Mean ambulatory brachial systolic pressure during self-reported sleeping hours
Measured: 4 weeks
Daytime Central Diastolic Pressure
Mean ambulatory central diastolic pressure during self-reported waking hours
Measured: 4 weeks
Nighttime Central Diastolic Pressure
Mean ambulatory central diastolic pressure during self-reported sleeping hours
Measured: After 4 weeks in each treatment arm
Daytime Brachial Diastolic Pressure
Mean ambulatory brachial diastolic pressure during self-reported waking hours
Measured: 4 weeks
Nighttime Brachial Diastolic Pressure
Mean ambulatory brachial diastolic pressure during self-reported sleeping hours
Measured: 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
Measured: 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
Measured: After 4 weeks in each treatment arm

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Dec 2014

First posted27 Dec 2021
Study startFeb 2013
Primary completionSep 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Random-order-entry 3-way crossover of active treatments; all participants receive all 3 active treatments with 6 possible experimental sequences (arms)
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05170061
Sponsor's protocol ID: BYS-IT-76
Acronym: ACRPP
Status last verified: May 2025
First submitted: 22 Dec 2014
Last updated: 8 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ambulatory 24-Hour Cardiac Oxygen Consumption and Blood Pressure-Heart Rate Variability: Effects of Nebivolol and Valsartan Alone and in Combination
ClinicalTrials.gov ID: NCT05170061
Acronym / sponsor ID: ACRPP / BYS-IT-76
Conditions: Hypertension
Keywords: Myocardial oxygen consumption, Systolic blood pressure, Diastolic blood pressure, Variability in hemodynamic indicators, Valsartan, Nebivolol, IEM ambulatory monitoring
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: State University of New York at BuffaloUniversity, hospital or other
Study start: Feb 2013
Primary completion: Sep 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 27 Dec 2021 (actual)
Results: Posted 8 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6
Model description: Random-order-entry 3-way crossover of active treatments; all participants receive all 3 active treatments with 6 possible experimental sequences (arms)

Arm	Type	Receives
Sequence 1: Nebivolol first, then valsartan, then combination of nebivolol/valsartan	Active comparator	Drug: Nebivolol, Drug: Valsartan, Drug: Nebivolol/valsartan combinationNebivolol, 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	Drug: Nebivolol, Drug: Valsartan, Drug: Nebivolol/valsartan combinationNebivolol, 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	Drug: Nebivolol, Drug: Valsartan, Drug: Nebivolol/valsartan combinationValsartan, 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 first, then combination of nebivolol/valsartan, then Nebivolol,	Active comparator	Drug: Nebivolol, Drug: Valsartan, Drug: Nebivolol/valsartan combinationValsartan, 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	Drug: Nebivolol, Drug: Valsartan, Drug: Nebivolol/valsartan combinationCombination 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	Drug: Nebivolol, Drug: Valsartan, Drug: Nebivolol/valsartan combinationCombination 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects with chronic hypertension, treated or untreated

Key exclusion criteria (13 listed)

Subjects with any of the following conditions will be excluded:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NebivololAlso: BystolicNebivolol 20 mg daily (1 week) followed by nebivolol 40 mg daily (3 weeks) followed by nebivolol 20 mg daily (1 week)	Drug	Sequence 1: Nebivolol first, then valsartan, then combination of nebivolol/valsartan, Sequence 2: Nebivolol first, then combination of nebivolol/valsartan; then valsartan, Sequence 3: Valsartan first, then Nebivolol, then combination of nebivolol/valsartan,, Sequence 4: Valsartan first, then combination of nebivolol/valsartan, then Nebivolol,, Sequence 5: Combination of nebivolol/valsartan first, then Nebivolol, then Valsartan,, Sequence 6: Combination of nebivolol/valsartan first, then Valsartan, then Nebivolol, ,
ValsartanAlso: DiovanValsartan 160 mg daily (1 week) followed by valsartan 320 mg daily (3 weeks) followed by valsartan 160 mg daily (1 week).	Drug	Sequence 1: Nebivolol first, then valsartan, then combination of nebivolol/valsartan, Sequence 2: Nebivolol first, then combination of nebivolol/valsartan; then valsartan, Sequence 3: Valsartan first, then Nebivolol, then combination of nebivolol/valsartan,, Sequence 4: Valsartan first, then combination of nebivolol/valsartan, then Nebivolol,, Sequence 5: Combination of nebivolol/valsartan first, then Nebivolol, then Valsartan,, Sequence 6: Combination of nebivolol/valsartan first, then Valsartan, then Nebivolol, ,
Nebivolol/valsartan combinationAlso: Diovan/BystolicValsartan/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)	Drug	Sequence 1: Nebivolol first, then valsartan, then combination of nebivolol/valsartan, Sequence 2: Nebivolol first, then combination of nebivolol/valsartan; then valsartan, Sequence 3: Valsartan first, then Nebivolol, then combination of nebivolol/valsartan,, Sequence 4: Valsartan first, then combination of nebivolol/valsartan, then Nebivolol,, Sequence 5: Combination of nebivolol/valsartan first, then Nebivolol, then Valsartan,, Sequence 6: Combination of nebivolol/valsartan first, then Valsartan, then Nebivolol, ,

Primary outcome

ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI)
Time frame: 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).

21 secondary outcomes

Cuff SBP
Time frame: After 4 weeks in each treatment arm
Cuff DBP
Time frame: After 4 weeks in each treatment arm
Ambulatory Brachial Double Product
Time frame: After 4 weeks in each treatment arm
Ambulatory Mean Heart Rate
Time frame: After 4 weeks in each treatment arm
Ambulatory Mean Central Diastolic BP
Time frame: After 4 weeks in each treatment arm
24-hour Brachial Systolic BP
Time frame: 4 weeks
24-hour Brachial Diastolic BP
Time frame: After 4 weeks in each treatment arm
Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI)
Time frame: After 4 weeks in each treatment arm
Nighttime ACRPP
Time frame: After 4 weeks in each treatment arm
Daytime Heart Rate
Time frame: After 4 weeks in each treatment arm
Nighttime Heart Rate
Time frame: 4 weeks
Daytime Central Systolic Pressure
Time frame: After 4 weeks in each treatment arm
Nighttime Central Systolic Pressure
Time frame: 4 weeks
Daytime Brachial Systolic Pressure
Time frame: After 4 weeks in each treatment arm
Nighttime Brachial Systolic Pressure
Time frame: 4 weeks
Daytime Central Diastolic Pressure
Time frame: 4 weeks
Nighttime Central Diastolic Pressure
Time frame: After 4 weeks in each treatment arm
Daytime Brachial Diastolic Pressure
Time frame: 4 weeks
Nighttime Brachial Diastolic Pressure
Time frame: After 4 weeks in each treatment arm
Ambulatory Daytime Brachial Rate-pressure Product
Time frame: After 4 weeks in each treatment arm
Ambulatory Nighttime Brachial Rate-pressure Product
Time frame: After 4 weeks in each treatment arm

Results and safety

Results posted to the registry on 8 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Nebivolol, Valsartan, Combination Nebivolol/Valsartan	5	5
Sequence 2: Nebivolol, Combination Nebivolol/Valsartan, Valsartan	5	5
Sequence 3: Valsartan, Nebivolol, Combination Nebivolol/Valsartan	4	4
Sequence 4: Valsartan, Combination Nebivolol/Valsartan, Nebivolol	4	4
Sequence 5: Combination Nebivolol/Valsartan, Nebivolol, Valsartan	4	4
Sequence 6: Combination Nebivolol/Valsartan, Valsartan, Nebivolol	4	4

Primary outcome: ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI)

Time frame: measurement after 4 weeks in each treatment arm. Mean (Standard Deviation). Unit: mmHg*beats/min

Measure	Nebivolol n = 26	Valsartan n = 26	Nebivolol/Valsartan n = 26
Value	2531 (400)	2824 (530)	2484 (368)

Nebivolol vs Valsartan vs Nebivolol/Valsartan: p = 0.05, t-test, 2 sided

Population analysed: 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.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 weeks for each participant; approximately 1-year for the study overall. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nebivolol	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Valsartan	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Nebivolol/Valsartan	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Limitations and caveats (from the sponsor): Relatively small sample size limits extrapolation. Small number of non-blacks precludes racial stratification.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26116459Izzo 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph L Izzo, MD principal investigator

SUNY Buffalo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nebivolol, Valsartan and Nebivolol/valsartan combination in people with Hypertension, run by State University of New York at Buffalo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI) (time frame: measurement after 4 weeks in each treatment arm). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05170061, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.