Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

Phase 4CompletedNCT00734630

Forest Laboratories491 enrolled

Overview

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

491

Conditions

Hypertension

Interventions

nebivololDRUG

Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

PlaceboDRUG

Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, ambulatory outpatients 18-85 years old at screening * Have a history of hypertension * Qualifying laboratory results Exclusion Criteria: * Severe hypertension, including chronic kidney disease * Documented congestive heart failure * Have clinically significant respiratory, liver, or heart disease * History of stroke, heart attack, or heart surgery in the last 6 months * Have a history of hypersensitivity to nebivolol or other beta blockers.

Locations (75)

Outcomes

Primary Outcomes

Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12

Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).

Time frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

Secondary Outcomes

Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12

Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).

Time frame: From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

Data from ClinicalTrials.gov

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Forest Investigative Site 070

Gulf Shores, Alabama, United States

Forest Investigative Site 092

Huntsville, Alabama, United States

Forest Investigative Site 058

Mesa, Arizona, United States

Forest Investigative Site 059

Tempe, Arizona, United States

Forest Investigative Site 024

Anaheim, California, United States

Forest Investigative Site 012

Bell Gardens, California, United States

Forest Investigative Site 026

Chino, California, United States

Forest Investigative Site 083

Costa Mesa, California, United States

Forest Investigative Site 030

Los Angeles, California, United States

Forest Investigative Site 053

Orange, California, United States

...and 65 more locations