Nebivolol in Patients With Systolic Stage 2 Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Forest Investigative Site 008, Foley, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nebivolol

Drug

5 mg, titrated to 20 mg, once daily oral administration

Other names: Bystolic

Placebo

Drug

5 mg or 20 mg once daily, oral administration

Primary outcomes

Change From Baseline in Mean Seated Systolic Blood Pressure After 6 Weeks of Nebivolol Monotherapy

Time frame: 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

Time frame: Change from Baseline (Week 0) to Visit 4 (Week 6)

Office blood pressure measured at trough by automatic oscillometric device.

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of 5 mg or 20 mg Nebivolol Once Daily on Blood Pressure in Patients With Systolic Stage 2 Hypertension

Acronym: NEB-MD-20

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2011
First posted: Jan 27, 2010
Registry last updated: Jan 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed