A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Nebivolol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00770861

NEB-MD-16

Details and patient eligibility

About

This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension

Enrollment: 277 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female outpatients 18 to 80 years of age, self-identified as Hispanic or Latino ethnicity
• Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
• Meet criteria for stage I or II hypertension
• Currently not treated, or being treated with no more than two anti-hypertensive medications

Exclusion criteria

• Secondary hypertension
• Are taking three or more antihypertensive agents
• Have uncontrolled or poorly controlled diabetes mellitus type I or type II
• Evidence of other concurrent disease or conditions that might interfere with the conduct of the study
• Participation in any investigational study within 30 days of Screening (Visit 1).
• Have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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277 participants in 2 patient groups, including a placebo group

Nebivolol

Active Comparator group

Description:

Nebivolol 5 mg, 5-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets, oral administration ; Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets, oral administration

Treatment:

Drug: Nebivolol

Placebo

Placebo Comparator group

Description:

Matching placebo tablets, oral administration

Treatment:

Drug: Placebo