A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients
Information source: Forest Laboratories
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Nebivolol (Drug); Metoprolol ER (TM) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Forest Laboratories Official(s) and/or principal investigator(s):
David Bharucha, MD, PhD, Study Director, Affiliation: Forest Laboratories
Overall contact:
Sandy Beaird, Phone: 1-800-678-1605, Ext: 66297, Email: info@forestpharm.com
Summary
The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another
beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the
mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other
biomarkers.
Clinical Details
Official title: Effect of Nebivolol on Forearm Vasodilation, Nitric Oxide Bioavailability, and Oxidative Stress in Patients With Stage 1/2 Hypertension
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Pre- and Post-ischemia forearm vascular resistance (FVR)
Secondary outcome: Pre- and Post-ischemia forearm blood flow (FBF)
Detailed description:
This study is double blind (neither the patient nor the physician will know when which drug
is being administered). It is being conducted at one research center in the United States.
The study consists of 14 study visits over about 4 months.
During all of these visits, patients will undergo routine health exams. At two of the
visits, patients will complete special tests on three consecutive days, one before the
administration of study drug and one after the administration of the study drug that the
patient had been receiving for the prior ten weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female, ambulatory outpatients 18-79 years old at screening
- Minimum 2-year history of Stage I/II hypertension
- Qualifying blood pressure criteria for study entry and for randomization
- Willing to adhere to the dietary compliance and undergo protocol procedures
- Have a lifestyle that will permit him/her to attend all evaluations, including those
conducted on consecutive days
Exclusion Criteria:
- Have any form of secondary hypertension
- Have clinically significant respiratory or cardiovascular disease
- Presence/history of coronary artery disease or peripheral vascular disease
- Have diabetes mellitus, Type I or II
- Have a history of hypersensitivity to nebivolol, metoprolol, or any beta-blocker
Locations and Contacts
Sandy Beaird, Phone: 1-800-678-1605, Ext: 66297, Email: info@forestpharm.com
Forest Investigative Site, Houston, Texas 77030, United States; Recruiting
Additional Information
Starting date: March 2008
Last updated: January 12, 2009
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