A Study on the Long-term Efficacy of Nebivolol After Withdrawal of Therapy

Forest Laboratories207 enrolled

Overview

This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

207

Conditions

Hypertension

Interventions

NebivololDRUG

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

PlaceboDRUG

Matching placebo tablets, oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * male and female outpatients 18 to 79 years of age * 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: * type 1 or type 2 diabetes * secondary hypertension * evidence of other concurrent disease or conditions that might interfere with the conduct of the study * treatment with any investigational study drug within 30 days of Screening (Visit 1) * have a history of hypersensitivity to nebivolol or other β-blockers

Locations (26)

Forest Investigative Site

Outcomes

Primary Outcomes

Trough Sitting Diastolic Blood Pressure

Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral diastolic blood pressure measured at drug trough.

Time frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)

Secondary Outcomes

Trough Sitting Systolic Blood Pressure

Change from baseline, week 0 (Visit 9) to Week 4 (Visit 12) in peripheral systolic blood pressure measured at drug trough.

Time frame: From baseline, week 0 (Visit 9) to week 4 (Visit 12)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.