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Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01202175
Recruitment Status : Completed
First Posted : September 15, 2010
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):

Study Description
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 80-89 mmHg) blood pressure. The investigators plan to investigate whether these subjects have the same markers (such as microscopic protein in the urine or C-reactive protein in the blood) in the blood and urine that people with high blood pressure have, and whether they are improved before and after taking the beta-blocker nebivolol.

Condition or disease Intervention/treatment Phase
Pre-hypertension Hypertension Drug: Nebivolol Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of the Novel Beta-adrenergic Antagonist Nebivolol (Bystolic) on Prehypertensive Subjects at Genetic Risk of Hypertension: Implications for Inflammation, Endothelial Dysfunction, and Oxidative Stress.
Study Start Date : July 2010
Primary Completion Date : June 2012
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nebivolol Drug: Nebivolol
Oral nebivolol 2.5-5mg once daily
Other Name: Bystolic
Placebo Comparator: Sugar pill Drug: Nebivolol
Oral nebivolol 2.5-5mg once daily
Other Name: Bystolic

Outcome Measures

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Urine microalbumin [ Time Frame: 8 weeks ]
  2. nitric oxide [ Time Frame: 8 weeks ]
  3. plasma glucose and insulin [ Time Frame: 8 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • • 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 Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202175

United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Forest Laboratories
Principal Investigator: Daniel O'Connor, MD University of California, San Diego
More Information

Responsible Party: Daniel O'Connor, Professor of medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01202175     History of Changes
Other Study ID Numbers: 100353
First Posted: September 15, 2010    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Keywords provided by Daniel O'Connor, University of California, San Diego:
Genetic risk of hypertension

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Adrenergic Antagonists
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs