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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00648895

NEB-MD-08

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

12 participants in 2 patient groups

1

Active Comparator group

Description:

Nebivolol

Treatment:

Drug: Nebivolol

2

Active Comparator group

Description:

Metoprolol ER (TM)

Treatment:

Drug: Metoprolol ER (TM)