Status:
COMPLETED
Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Forest Laboratories
Conditions:
Pre-hypertension
Hypertension
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
The investigators aim to evaluate subjects at high risk of future development of hypertension, those with a family history of hypertension and/or that already have high normal(SBP 120-139 mmHg or DBP ...
Eligibility Criteria
Inclusion
- • Prehypertensive male and female subjects with SBP =120-139 or DBP =80-89 with at least one known family member (must be diagnosed prior to the age of 60) with essential hypertension (confirmation may be sought).
- All ethnicities
- Non-smokers and non-drug abusers, no current smoking or illicit drug use in the prior 3 months.
- Aged 18-40 years
- No known serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus
- Subjects will need to remain in the San Diego area for the duration of the study (10 weeks) and be accessible by telephone or email.
- Female subjects must be willing to use a birth control method, such as abstinence, birth control pills, diaphragm, condom, or intrauterine device to prevent pregnancy during the study.
Exclusion
- Subjects with SBP \>140 or SBP\<120 or DBP \>90 and DBP\<80
- We will exclude subjects whose family members have known secondary etiologies for hypertension such as hyperaldosteronism or Cushing's Disease.
- Subjects cannot have a chronic medical condition that is actively treated by a physician, such as liver impairment, diabetes, or kidney disease
- History of bronchial asthma or chronic obstructive pulmonary disease
- Subjects cannot be on any anti-hypertensive medications for any reason.
- Subjects may not have previous intolerance, hypersensitivity, or allergy to any beta blocker therapy or may have contraindications to beta blocker therapy such as asthma, bradycardia, etc.
- Subjects may not be taking medications which may affect the metabolism of nebivolol, such as those that inhibit CYP2D6 (such as fluoxetine or cimetidine)
- Nursing women, pregnant women, or those that plan to become pregnant in the study period will also be excluded. (Pregnancy tests will be performed on all female subjects at the start of the study)
- Subjects with pulse rate consistently \<60 beats per minute or evidence of arrythmias including atrioventricular block.
- Those that have smoked or used illicit drugs within the past 3 months
- Female subjects that are not willing to use a birth control method, such as abstinence, birth control pills, diaphragm, condom, or intrauterine device to prevent pregnancy during the study.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01202175
Start Date
July 1 2010
End Date
June 1 2013
Last Update
August 21 2019
Active Locations (1)
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1
University of California, San Diego
La Jolla, California, United States, 92093