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Phase 3 N=26 Randomized Triple-blind Treatment

24 Hour Ambulatory Cardiac Oxygen Consumption

Hypertension

Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI) — 2531; 2824; 2484 mmHg*beats/min — p=0.05

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Nebivolol (Drug); Valsartan (Drug); Nebivolol/valsartan combination (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
State University of New York at Buffalo
Primary completion
Sep 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI)
2531; 2824; 2484 0.05
SECONDARY
Cuff SBP
150; 148; 146 0.05
SECONDARY
Cuff DBP
84; 87; 81 0.05
SECONDARY
Ambulatory Brachial Double Product
9329; 11239; 9154 0.05
SECONDARY
Ambulatory Mean Heart Rate
64; 77; 63 0.05
SECONDARY
Ambulatory Mean Central Diastolic BP
91; 90; 89 0.05
SECONDARY
24-hour Brachial Systolic BP
147; 143; 145 0.05
SECONDARY
24-hour Brachial Diastolic BP
89; 88; 87 0.05
SECONDARY
Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI)
2482; 2817; 2423 0.05
SECONDARY
Nighttime ACRPP
2454; 2564; 2309 0.05
SECONDARY
Daytime Heart Rate
64; 81; 64 0.05
SECONDARY
Nighttime Heart Rate
64; 74; 63 0.05
SECONDARY
Daytime Central Systolic Pressure
138; 135; 136 0.05
SECONDARY
Nighttime Central Systolic Pressure
135; 130; 131 0.05
SECONDARY
Daytime Brachial Systolic Pressure
149; 146; 147 0.05
SECONDARY
Nighttime Brachial Systolic Pressure
145; 138; 141 0.05
SECONDARY
Daytime Central Diastolic Pressure
93; 93; 92 0.05
SECONDARY
Nighttime Central Diastolic Pressure
89; 86; 85 0.05
SECONDARY
Daytime Brachial Diastolic Pressure
91; 91; 89 0.05
SECONDARY
Nighttime Brachial Diastolic Pressure
87; 83; 83 0.05
SECONDARY
Ambulatory Daytime Brachial Rate-pressure Product
9528; 11869; 9335 0.05
SECONDARY
Ambulatory Nighttime Brachial Rate-pressure Product
9284; 10338; 8830 0.05

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05170061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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