Status:
COMPLETED
Nebivolol Versus Metoprolol: Sodium Sensitivity
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Forest Laboratories
Conditions:
Hypertension
Eligibility:
FEMALE
46+ years
Phase:
PHASE4
Brief Summary
Research objectives The objective of this randomized, placebo-controlled, 2 period crossover clinical trial is to determine the effects of nebivolol versus metoprolol on ambulatory blood pressure, th...
Detailed Description
This investigation consisted of a randomized, open-label, 2-Treatment Period (metoprolol versus nebivolol) crossover clinical trial conducted in postmenopausal women with stage 1 hypertension. Ninetee...
Eligibility Criteria
Inclusion
- Women \> 45 years of age.
- Self-identified as Hispanic ethnicity.
- Have hypertension defined as:
- Systolic blood pressure 140-159 mm Hg off antihypertensive medications
- Diastolic 90-99 mm Hg off antihypertensive medications
- 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 medications
- 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.
- No clinically significant or unstable coexisting medical condition in the estimation of the study PI
- No clinically significant abnormalities of physical exam or laboratory data in the estimation of the PI
- Concomitant medications will be evaluated on a case by case basis by the study PI
- Renal function as assessed by a Cockcroft-Gault estimated glomerular filtration rate (GFR) of \>70 ml/min
- Signed informed consent and the ability to understand the study and its procedures
Exclusion
- Inability to understand the study or provide informed consent
- History of adverse effects or intolerance to nebivolol or beta-blockers
- Previous treatment with nebivolol within the preceding six months.
- Significant or unstable cardiovascular, pulmonary, renal, gastrointestinal, hepatic, endocrine, or central nervous system as determined by the principal investigator.
- Clinically significant abnormalities of physical examination or laboratory data as determined by the principal investigator.
- 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.
- Receiving treatment with diuretics, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, 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.
- Grapefruit and Seville oranges are not allowed at any time during the study.
- Any disease or condition that, in the opinion of the investigator, could compromise the absorption, accumulation, metabolism, or excretion of the study medication.
- Current alcohol or drug abuse.
- Smoking of more than 10 cigarettes per day.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00992056
Start Date
December 1 2010
End Date
May 1 2012
Last Update
June 8 2017
Active Locations (1)
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1
Division of Clinical Pharmacology Clinical Pharmacology Research Unit (CPRU) 1500 NW 12th Ave 15-West.
Miami, Florida, United States, 33136