NCT01057251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

36 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 11, 2012

Completed
Last Updated

January 11, 2012

Status Verified

December 1, 2011

Enrollment Period

9 months

First QC Date

January 26, 2010

Results QC Date

December 6, 2011

Last Update Submit

December 6, 2011

Conditions

Hypertension

Keywords

NebivololBystolic TMHypertensionStage 2 Hypertension

Outcome Measures

Primary Outcomes (2)

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

    Office blood pressure measured at trough by automatic oscillometric device.

    Change from Baseline Visit 1 (week 0) to Visit 4 (Week 6)

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

    Office blood pressure measured at trough by automatic oscillometric device.

    Change from Baseline (Week 0) to Visit 4 (Week 6)

Study Arms (2)

1

EXPERIMENTAL
Drug: Nebivolol

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

NebivololDRUG

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

Also known as: Bystolic
1
PlaceboDRUG

5 mg or 20 mg once daily, oral administration

2

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Forest Investigative Site 008

Foley, Alabama, 36535, United States

Location

Forest Investigative Site 021

Montgomery, Alabama, 36117, United States

Location

Forest Investigative Site 006

Chino, California, 91710, United States

Location

Forest Investigative Site 002

Long Beach, California, 90806, United States

Location

Forest Investigative Site 004

Los Angeles, California, 90057, United States

Location

Forest Investigative Site 020

Temecula, California, 92591, United States

Location

Forest Investigative Site 028

Coral Gables, Florida, 33134, United States

Location

Forest Investigative Site 014

Daytona Beach, Florida, 32114, United States

Location

Forest Investigative Site 001

Fort Lauderdale, Florida, 33308, United States

Location

Forest Investigative Site 037

Fort Lauderdale, Florida, 33316, United States

Location

Forest Investigative Site 033

Hialeah, Florida, 33012, United States

Location

Forest Investigative Site 026

Jacksonville, Florida, 32216, United States

Location

Forest Investigative Site 017

Miami, Florida, 33133, United States

Location

Forest Investigative Site 010

Miami, Florida, 33169, United States

Location

Forest Investigative Site 030

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 009

Atlanta, Georgia, 30338, United States

Location

Forest Investigative Site 031

Augusta, Georgia, 30904, United States

Location

Forest Investigative Site 039

Meridian, Idaho, 83646, United States

Location

Forest Investigative Site 007

Auburn, Maine, 04210, United States

Location

Forest Investigative Site 038

Baltimore, Maryland, 21204, United States

Location

Forest Investigative Site 011

Baltimore, Maryland, 21209, United States

Location

Forest Investigative Site 029

Prince Frederick, Maryland, 20678, United States

Location

Forest Investigative Site 023

Paw Paw, Michigan, 49079, United States

Location

Forest Investigative Site 005

Florissant, Missouri, 63033, United States

Location

Forest Investigative Site 041

Las Vegas, Nevada, 89106, United States

Location

Forest Investigative Site 040

New York, New York, 10010, United States

Location

Forest Investigative Site 012

Hickory, North Carolina, 28601, United States

Location

Forest Investigative Site 027

Salisbury, North Carolina, 28144, United States

Location

Forest Investigative Site 024

Harleysville, Pennsylvania, 19438, United States

Location

Forest Investigative Site 013

Charleston, South Carolina, 29407, United States

Location

Forest Investigative Site 035

Greenville, South Carolina, 29605, United States

Location

Forest Investigative Site 018

Mt. Pleasant, South Carolina, 29464, United States

Location

Forest Investigative Site 022

Simpsonville, South Carolina, 29681, United States

Location

Forest Investigative Site 003

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 032

Corpus Christi, Texas, 78404, United States

Location

Forest Investigative Site 025

Richmond, Virginia, 23219, United States

Location

Related Publications (1)

  • Lewin A, Punzi H, Luo X, Stapff M. Nebivolol monotherapy for patients with systolic stage II hypertension: results of a randomized, placebo-controlled trial. Clin Ther. 2013 Feb;35(2):142-52. doi: 10.1016/j.clinthera.2012.12.015. Epub 2013 Jan 15.

    PMID: 23332366DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Manfred Stapff, MD, PhD
Organization
Forest Research Institute
manfred.stapff@frx.com
201-427-8000

Study Officials

  • Manfred Stapff, MD, PhD

    Forest Research Institute, a Subsidiary of Forest Laboratories Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

January 11, 2012

Results First Posted

January 11, 2012

Record last verified: 2011-12

Locations

US(36)