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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

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

June 24, 2010
May 24, 2014
July 2010
June 2012   (final data collection date for primary outcome measure)
Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01202175 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Pre-hypertension
  • Hypertension
Drug: Nebivolol
Oral nebivolol 2.5-5mg once daily
Other Name: Bystolic
  • Experimental: Nebivolol
    Intervention: Drug: Nebivolol
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Nebivolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2013
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01202175
100353
Not Provided
Daniel O'Connor, University of California, San Diego
University of California, San Diego
Forest Laboratories
Principal Investigator: Daniel O'Connor, MD University of California, San Diego
University of California, San Diego
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP