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

NCT01202175 | Completed Phase 4 Results

• 1 other identifier: 100353
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-hypertension; Hypertension

Keywords

Genetic risk of hypertension

Outcome Measures

Primary Outcomes (8)

• Aortic Systolic Blood Pressure (SBP)

  Basline (visit 1) and 8 weeks (visit 2)

• Aortic Diastolic Blood Pressure (DBP)

  Basline (visit 1) and 8 weeks (visit 2)

• Aortic Mean Arterial Pressure (MAP)

  Basline (visit 1) and 8 weeks (visit 2)

• Aortic Pulse Pressure

  Basline (visit 1) and 8 weeks (visit 2)

• Aortic Augmentation Pressure

  Basline (visit 1) and 8 weeks (visit 2)

• Aortic Augmentation Index for Heart Rate

  Basline (visit 1) and 8 weeks (visit 2)

• Pulse Wave Velocity

  Basline (visit 1) and 8 weeks (visit 2)

• Heart Rate, Beats Per a Minute

  Basline (visit 1) and 8 weeks (visit 2)

Secondary Outcomes (4)

• Urinary Nitric Oxide Excretion

  Basline (visit 1) and 8 weeks (visit 2)

• Urinary Isoprostane Excretion

  Basline (visit 1) and 8 weeks (visit 2)

• Urinary Hydrogen Peroxide Excretion

  Baseline (visit 1) and 8 Weeks (visit 2)

• Plasma Interleukin Levels

  Basline (visit 1) and 8 weeks (visit 2)

Study Arms (2)

Nebivolol

EXPERIMENTAL

Drug: Nebivolol

Sugar pill

PLACEBO COMPARATOR

Drug: Nebivolol

Interventions

Nebivolol DRUG

Oral nebivolol 2.5-5mg once daily

Also known as: Bystolic

Nebivolol; Sugar pill

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Forest Laboratories: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Prehypertension; Hypertension

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Joachim H. Ix, MD, MAS
• Organization: Univeristy of California, San Diego

joeix@ucsd.edu

858-552-7528

Study Officials

• Daniel O'Connor, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: September 15, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: August 21, 2019
• Results First Posted: August 21, 2019

Record last verified: 2019-07

Locations

US (1)