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OpenTrials
Completed

NCT Number: NCT01202175

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nebivolol

Drug

Oral nebivolol 2.5-5mg once daily

Other names: Bystolic

Primary outcomes

  1. Aortic Systolic Blood Pressure (SBP)

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

  2. Aortic Diastolic Blood Pressure (DBP)

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

  3. Aortic Mean Arterial Pressure (MAP)

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

  4. Aortic Pulse Pressure

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

  5. Aortic Augmentation Pressure

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

  6. Aortic Augmentation Index for Heart Rate

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

  7. Pulse Wave Velocity

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

  8. Heart Rate, Beats Per a Minute

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

Secondary outcomes

  1. Urinary Nitric Oxide Excretion

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

  2. Urinary Isoprostane Excretion

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

  3. Urinary Hydrogen Peroxide Excretion

    Time frame: Baseline (visit 1) and 8 Weeks (visit 2)

  4. Plasma Interleukin Levels

    Time frame: Basline (visit 1) and 8 weeks (visit 2)

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Forest Laboratories

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Sep 15, 2010
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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