Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

Forest Laboratories641 enrolled

Overview

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

641

Conditions

Hypertension

Interventions

NebivololDRUG

Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration

PlaceboDRUG

Dose-match placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 54 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female outpatients, of age 18 - 54 years * Patients diagnosed with stage 1 or stage 2 essential hypertension * Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant Exclusion Criteria: * Secondary hypertension or severe hypertension * History of Type 1 diabetes mellitus * A medical contraindication to discontinuing a current antihypertensive therapy * Clinically significant respiratory disease that prohibit use of a beta blocker

Locations (75)

Outcomes

Primary Outcomes

Trough Seated Diastolic Blood Pressure (DBP)

Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.

Time frame: Change from Baseline to Week 8

Secondary Outcomes

Trough Seated Systolic Blood Pressure (SBP)

Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.

Time frame: Change from Baseline to Week 8

Data from ClinicalTrials.gov

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Forest Investigative Site 065

Phoenix, Arizona, United States

Forest Investigative Site 067

Phoenix, Arizona, United States

Forest Investigative Site 070

Phoenix, Arizona, United States

Forest Investigative Site 049

Buena Park, California, United States

Forest Investigative Site 034

Burbank, California, United States

Forest Investigative Site 039

Costa Mesa, California, United States

Forest Investigative Site 024

Fountain Valley, California, United States

Forest Investigative Site 020

Fresno, California, United States

Forest Investigative Site 021

Fresno, California, United States

Forest Investigative Site 040

Greenbrae, California, United States

...and 65 more locations