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A Study of the Effect of Nebivolol to Evaluate Its Vasodilatory Effects in Hypertensive Patients

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nebivolol (Drug); Metoprolol ER (TM) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Tatjana Lukic, MD., M.Sc., Study Director, Affiliation: Forest Research Institute, Inc., a Subsidiary of Forest Laboratories, Inc.

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage Change From Baseline to End of Treatment for the Difference Between the Post-ischemia and Pre-ischemia Forearm Vascular Resistance (FVR).

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

Forest Investigative Site, Houston, Texas 77030, United States
Additional Information

Starting date: November 2007
Last updated: August 30, 2010

Page last updated: August 23, 2015

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