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

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

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 008; 🇺🇸 Foley, Alabama, United States

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

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

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

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

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

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

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

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

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

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