Overview

This trial is active, not recruiting.

Conditions prehypertension, hypertension
Treatments nebivolol, metoprolol, placebo
Phase phase 4
Sponsor University of Colorado, Boulder
Collaborator Forest Laboratories
Start date May 2011
End date December 2016
Trial size 48 participants
Trial identifier NCT01395329, BYS-MD-57

Summary

The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Arm
(Active Comparator)
nebivolol Bystolic
5 mg tablet to be taken by mouth once per day for 12 weeks
(Active Comparator)
metoprolol Toprol-XL
100 mg tablet to be taken by mouth once per day for 12 weeks
(Placebo Comparator)
placebo
gelatin capsule to be taken by mouth once per day for 12 weeks

Primary Outcomes

Measure
ET-1-mediated vasoconstrictor tone
time frame: Forearm blood flow will be measured at week 3 (before the 12 week drug or placebo intervention) and at week 15 (after the 12 week drug or placebo intervention).

Eligibility Criteria

Male or female participants from 45 years up to 65 years old.

Inclusion Criteria: - Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years. - Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure >130 mmHg and < 160 mm Hg and/or diastolic blood pressure >80 mmHg and < 100 mm Hg. - All of the women in the study will be postmenopausal (at least 1 year from last menstrual cycle) and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period. - Lastly, candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study. Exclusion Criteria: - Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits) - Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication an aspirin) medications will not be eligible. - Fasting plasma glucose >126 mg/dL. - Potential candidates with a resting heart rate of < 50 beats/minute will be excluded. - Use of hormone replacement therapy. - In hypertensive subjects, a seated systolic blood pressure greater than 160 mmHg or a seated diastolic blood pressure greater than 100 mmHg.

Additional Information

Official title Nebivolol and the Endothelin (ET)-1 System
Principal investigator Christopher A DeSouza, Ph.D.
Description 1. The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. 2. The investigators further hypothesize that reducing ET-1 vasoconstrictor activity contributes to the improvement in endothelial vasodilator function associated with nebivolol.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Boulder.