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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Daniel O'Connor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01202175
First received: June 24, 2010
Last updated: May 24, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Pre-hypertension
Hypertension
Drug: Nebivolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine microalbumin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • nitric oxide [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • plasma glucose and insulin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2010
Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202175

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

No publications provided

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
Study First Received: June 24, 2010
Last Updated: May 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
Genetic risk of hypertension

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Nebivolol
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on July 26, 2014