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

NCT ID: NCT01202175

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nebivolol

Group Type: EXPERIMENTAL

Nebivolol

Intervention Type: DRUG

Oral nebivolol 2.5-5mg once daily

Sugar pill

Group Type: PLACEBO_COMPARATOR

Nebivolol

Intervention Type: DRUG

Oral nebivolol 2.5-5mg once daily

Interventions

Nebivolol

Oral nebivolol 2.5-5mg once daily

Intervention Type: DRUG

Other Intervention Names

Bystolic

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Joachim H. Ix

Professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel O'Connor, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego

La Jolla, California, United States

Countries

United States

Other Identifiers

100353

Identifier Type: -

Identifier Source: org_study_id