Comparative Effects of Nebivolol Versus Placebo on Sodium Sensitivity of Blood Pressure in Hispanic Postmenopausal Women With Hypertension
Information source: University of Miami
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: nebivolol (Drug); Nebivolol (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Miami
2. 1 Research objectives:
The objective of this randomized, placebo-controlled, 2 period crossover clinical trial is
to determine the effects of nebivolol versus placebo on ambulatory blood pressure, the blood
pressure response to dietary sodium loading, and renal handling of an acute sodium load in
postmenopausal women with hypertension.
2. 1.1 Hypothesis:
Nebivolol will result in a blunted response of blood pressure to oral sodium administration
and improved handling of an intravenous sodium load in comparison with placebo in
hypertensive postmenopausal women.
2. 2 Research plan:
2. 2.1 Study design
The study will consist of a randomized crossover trial of the effects on salt sensitivity of
nebivolol. All study procedures will be carried out under the direct supervision of the
Principal Investigator in the outpatient and inpatient research unit of the University of
Miami Division of Clinical Pharmacology.
2. 2.2 Primary endpoints:
1. Change and percentage change in systolic, diastolic and mean blood pressure by ABPM
from final day of low sodium to the final day of high sodium in nebivolol versus
2. Differences in renal sodium excretion in response to an acute sodium load during
treatment with either nebivolol or placebo.
2. 2.3 Secondary endpoints
1. Change in clinic blood pressure following 4 weeks of outpatient nebivolol versus
2. Change in weight from final day of low sodium to the final day of high sodium in
nebivolol versus placebo
3. Change in 24-hour sodium and potassium excretion from last day of low sodium to last
day of high sodium
4. Asymmetrical dimethylarginine (ADMA)
Official title: Comparative Effects of Nebivolol Versus Placebo on Sodium Sensitivity of Blood Pressure in Hispanic Postmenopausal Women With Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Change and percentage change in systolic, diastolic and mean blood pressure by ABPM from final day of low sodium to the final day of high sodium in nebivolol versus placebo
Differences in renal sodium excretion in response to an acute sodium load during treatment with either nebivolol or placebo.
Minimum age: 46 Years.
Maximum age: N/A.
- Inclusion criteria for up to 20 participants
1. Women > 45 years of age.
2. Self-identified as Hispanic ethnicity.
3. Have hypertension defined as:
- Systolic blood pressure 140-159 mm Hg off antihypertensive medications
- Diastolic 90-99 mm Hg off antihypertensive medications
4. Blood pressure will be calculated as the mean of 3 consecutive office cuff
measurements at rest (sitting). In order to be eligible for treatment, subjects must
meet the above definition of hypertension at screening visits off antihypertensive
5. Natural menopause at least 1 year (no menstruation for 1 year) prior to screening or
had a bilateral oophorectomy at least 3 months prior to study participation.
6. No clinically significant or unstable coexisting medical condition in the estimation
of the study PI
7. No clinically significant abnormalities of physical exam or laboratory data in the
estimation of the PI
8. Concomitant medications will be evaluated on a case by case basis by the study PI
9. Renal function as assessed by a Cockroft-Gault estimated GFR of >70 ml/min
10. Signed informed consent and the ability to understand the study and its procedures
- Exclusion criteria
1. Inability to understand the study or provide informed consent
2. History of adverse effects or intolerance to nebivolol or beta-blockers
3. Previous treatment with nebivolol within the preceding six months.
4. Significant or unstable cardiovascular, pulmonary, renal, gastrointestinal,
hepatic, endocrine, or central nervous system as determined by the principal
5. Clinically significant abnormalities of physical examination or laboratory data
as determined by the principal investigator.
6. The subject has donated or lost more than 450 mL of blood or has received
transfusion of any blood or blood products within 30 days prior to screening.
7. Receiving treatment with diuretics, non-steroidal anti-inflammatory drugs
(NSAIDs), ASA, steroids, or other agents known to influence blood pressure,
renal function, or sodium sensitivity. Any concomitant medications will be
reviewed by the study PI on a case-by-case basis. In general, no concomitant
medication is preferred. Any medication may be tapered/discontinued with consent
of patient and at the discretion of the study PI.
8. Grapefruit and Seville oranges are not allowed at any time during the study.
9. Any disease or condition that, in the opinion of the investigator, could
compromise the absorption, accumulation, metabolism, or excretion of the study
10. Current alcohol or drug abuse.
11. Smoking of more than 10 cigarettes per day.
Locations and Contacts
Division of Clinical Pharmacology Clinical Pharmacology Research Unit (CPRU), 1500 NW 12th Ave 15-West. Miami, Florida 33136, United States; Not yet recruiting
Alberto B Alonso, MD, PA, Phone: 305-243-5625
Richard A Preston, MD, MSPH, Principal Investigator
Starting date: November 2009
Last updated: October 7, 2009