Trial record 10 of 22 for:
Open Studies | "Prehypertension"
Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Colorado, Boulder.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Christopher DeSouza, University of Colorado, Boulder
First received: March 5, 2012
Last updated: May 8, 2012
Last verified: May 2012
The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. The investigators further hypothesize that the improvement in the capacity of the vascular endothelium to release t-PA with nebivolol is mediated, in part, by the compound's antioxidant properties.
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
||Nebivolol and Endothelial Regulation of Fibrinolysis
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2014 (Final data collection date for primary outcome measure)
Active Comparator: Nebivolol
5 mg tablet to be taken by mouth once per day for 12 weeks
Other Name: Bystolic
Active Comparator: Metoprolol
100 mg tablet to be taken by mouth once per day for 12 weeks
Other Name: Toprol-XL
Placebo Comparator: Placebo
Gelatin capsule to be taken by mouth once per day for 12 weeks
|Ages Eligible for Study:
||45 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 >125 mmHg and <160 mmHg and/or diastolic >80 mmHg and <100 mmHg.
- All of the women in the study will be postmenopausal and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
- 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.
- 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 and 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 >160 mmHg or a seated diastolic blood pressure >100 mmHg will be excluded.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01595516
|UC-Boulder Clinical and Translational Research Center
|Boulder, Colorado, United States, 80309 |
|Contact 303-735-3056 |
|Principal Investigator: Christopher DeSouza, Ph.D. |
University of Colorado, Boulder
||Christopher DeSouza, Ph.D.
||University of Colorado at Boulder
No publications provided
||Christopher DeSouza, Professor, University of Colorado, Boulder
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 5, 2012
||May 8, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action