Nebivolol in Patients With Systolic Stage 2 Hypertension

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Placebo; Drug: Nebivolol

• Registration Number: NCT01057251
• Lead Sponsor: Forest Laboratories

Brief Summary

The primary object of this study is to evaluate the efficacy and safety of 6 weeks of nebivolol monotherapy compared with placebo in patients with systolic stage 2 hypertension.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Study Start: 2010-03
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2011-12
• Results First Submitted: 2011-12-06
• Results First Submitted QC: 2011-12-06
• Last Update Submitted: 2011-12-06
• Results First Posted: 2012-01-11
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 433

Inclusion Criteria

• male of female, 18 to 64 years of age at screening
• mean seated heart rate at least 60 bpm
• diagnosed systolic stage 2 hypertension
• unremarkable physical exam findings

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Exclusion Criteria

• high risk due to secondary hypertension or former stage 3 hypertension by JNC6
• concurrent conditions (reno, cardiovascular, obesity, thyroid, etc)
• currently taking medication that cannot be stopped during the course of the study
• participating other clinical trials
• member of the study center personnel
• documented drug abuse
• contra indication to beta blocker
• abnormal lab finding
• poor compliance
• other conditions judged by investigator that is not suitable for the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Nebivolol	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy	Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)	Office blood pressure measured at trough by automatic oscillometric device.
Change From Baseline in Mean Seated Diastolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy	Change from Baseline (Week 0) to Visit 4 (Week 6)	Office blood pressure measured at trough by automatic oscillometric device.

Trial Locations

Locations (36)

Forest Investigative Site 032; 🇺🇸 Corpus Christi, Texas, United States

Forest Investigative Site 009; 🇺🇸 Atlanta, Georgia, United States

Forest Investigative Site 038; 🇺🇸 Baltimore, Maryland, United States

Forest Investigative Site 011; 🇺🇸 Baltimore, Maryland, United States

Forest Investigative Site 033; 🇺🇸 Hialeah, Florida, United States

Forest Investigative Site 020; 🇺🇸 Temecula, California, United States

Forest Investigative Site 002; 🇺🇸 Long Beach, California, United States

Forest Investigative Site 006; 🇺🇸 Chino, California, United States

Forest Investigative Site 010; 🇺🇸 Miami, Florida, United States

Forest Investigative Site 030; 🇺🇸 Orlando, Florida, United States

Forest Investigative Site 031; 🇺🇸 Augusta, Georgia, United States

Forest Investigative Site 037; 🇺🇸 Fort Lauderdale, Florida, United States

Forest Investigative Site 008; 🇺🇸 Foley, Alabama, United States

Forest Investigative Site 012; 🇺🇸 Hickory, North Carolina, United States

Forest Investigative Site 021; 🇺🇸 Montgomery, Alabama, United States

Forest Investigative Site 018; 🇺🇸 Mt. Pleasant, South Carolina, United States

Forest Investigative Site 039; 🇺🇸 Meridian, Idaho, United States

Forest Investigative Site 029; 🇺🇸 Prince Frederick, Maryland, United States

Forest Investigative Site 007; 🇺🇸 Auburn, Maine, United States

Forest Investigative Site 022; 🇺🇸 Simpsonville, South Carolina, United States

Forest Investigative Site 014; 🇺🇸 Daytona Beach, Florida, United States

Forest Investigative Site 028; 🇺🇸 Coral Gables, Florida, United States

Forest Investigative Site 001; 🇺🇸 Ft. Lauderdale, Florida, United States

Forest Investigative Site 026; 🇺🇸 Jacksonville, Florida, United States

Forest Investigative Site 005; 🇺🇸 Florissant, Missouri, United States

Forest Investigative Site 004; 🇺🇸 Los Angeles, California, United States

Forest Investigative Site 035; 🇺🇸 Greenville, South Carolina, United States

Forest Investigative Site 024; 🇺🇸 Harleysville, Pennsylvania, United States

Forest Investigative Site 041; 🇺🇸 Las Vegas, Nevada, United States

Forest Investigative Site 040; 🇺🇸 New York, New York, United States

Forest Investigative Site 013; 🇺🇸 Charleston, South Carolina, United States

Forest Investigative Site 003; 🇺🇸 Memphis, Tennessee, United States

Forest Investigative Site 025; 🇺🇸 Richmond, Virginia, United States

Forest Investigative Site 023; 🇺🇸 Paw Paw, Michigan, United States

Forest Investigative Site 027; 🇺🇸 Salisbury, North Carolina, United States

Forest Investigative Site 017; 🇺🇸 Miami, Florida, United States