Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

NCT01415531 | Completed Phase 4 Results

• 1 other identifier: NEB-MD-28
• Study Type: interventional
• Target: 641
• Locations: 1 country
• Sites: 75

Brief Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Conditions

Hypertension

Keywords

Stage 1; Stage 2; Hypertension

Outcome Measures

Primary Outcomes (1)

• Trough Seated Diastolic Blood Pressure (DBP)

  Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.

  Change from Baseline to Week 8

Secondary Outcomes (1)

• Trough Seated Systolic Blood Pressure (SBP)

  Change from Baseline to Week 8

Study Arms (2)

1

EXPERIMENTAL

Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration

Drug: Nebivolol

2

PLACEBO COMPARATOR

Dose-matched placebo

Drug: Placebo

Interventions

Nebivolol DRUG

Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration

1

Placebo DRUG

Dose-match placebo

2

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female outpatients, of age 18 - 54 years
• Patients diagnosed with stage 1 or stage 2 essential hypertension
• Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

You may not qualify if:

• Secondary hypertension or severe hypertension
• History of Type 1 diabetes mellitus
• A medical contraindication to discontinuing a current antihypertensive therapy
• Clinically significant respiratory disease that prohibit use of a beta blocker

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (75)

Forest Investigative Site 065

Phoenix, Arizona, 85014, United States

Location

Forest Investigative Site 067

Phoenix, Arizona, 85014, United States

Location

Forest Investigative Site 070

Phoenix, Arizona, 85014, United States

Location

Forest Investigative Site 049

Buena Park, California, 90620, United States

Location

Forest Investigative Site 034

Burbank, California, 91505, United States

Location

Forest Investigative Site 039

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 024

Fountain Valley, California, 92708, United States

Location

Forest Investigative Site 020

Fresno, California, 93726, United States

Location

Forest Investigative Site 021

Fresno, California, 93726, United States

Location

Forest Investigative Site 040

Greenbrae, California, 94904, United States

Location

Forest Investigative Site 047

La Mesa, California, 91942, United States

Location

Forest Investigative Site 073

Los Angeles, California, 90057, United States

Location

Forest Investigative Site 077

Roseville, California, 95661, United States

Location

Forest Investigative Site 060

San Bernardino, California, 92404, United States

Location

Forest Investigative Site 054

San Francisco, California, 94115, United States

Location

Forest Investigative Site 018

Spring Valley, California, 91978, United States

Location

Forest Investigative Site 028

Denver, Colorado, 80220, United States

Location

Forest Investigative Site 059

Brooksville, Florida, 34601, United States

Location

Forest Investigative Site 033

Fort Lauderdale, Florida, 33306, United States

Location

Forest Investigative Site 006

Hallandale, Florida, 33009, United States

Location

Forest Investigative Site 044

Longwood, Florida, 32779, United States

Location

Forest Investigative Site 001

Miami, Florida, 33014, United States

Location

Forest Investigative Site 012

Miami, Florida, 33014, United States

Location

Forest Investigative Site 032

Miami, Florida, 33014, United States

Location

Forest Investigative Site 055

Miami, Florida, 33014, United States

Location

Forest Investigative Site 045

Oviedo, Florida, 32765, United States

Location

Forest Investigative Site 031

St. Petersburg, Florida, 33709, United States

Location

Forest Investigative Site 009

Atlanta, Georgia, 30084, United States

Location

Forest Investigative Site 007

Chicago, Illinois, 60611, United States

Location

Forest Investigative Site 004

Morton, Illinois, 61550, United States

Location

Forest Investigative Site 072

Evansville, Indiana, 47713, United States

Location

Forest Investigative Site 069

Newburgh, Indiana, 47630, United States

Location

Forest Investigative Site 025

Augusta, Kansas, 67010, United States

Location

Forest Investigative Site 029

Louisville, Kentucky, 40213, United States

Location

Forest Investigative Site 068

Madisonville, Kentucky, 42431, United States

Location

Forest Investigative Site 061

Metairie, Louisiana, 70005, United States

Location

Forest Investigative Site 057

New Orleans, Louisiana, 70119, United States

Location

Forest Investigative Site 058

New Orleans, Louisiana, 70119, United States

Location

Forest Investigative Site 008

Lutherville, Maryland, 21093, United States

Location

Forest Investigative Site 062

Fall River, Massachusetts, 02702, United States

Location

Forest Investigative Site 075

Paw Paw, Michigan, 49079, United States

Location

Forest Investigative Site 019

Brooklyn Center, Minnesota, 55430, United States

Location

Forest Investigative Site 017

Chaska, Minnesota, 55318, United States

Location

Forest Investigative Site 038

Belzoni, Mississippi, 39038, United States

Location

Forest Investigative Site 035

Olive Branch, Mississippi, 38654, United States

Location

Forest Investigative Site 023

Las Vegas, Nevada, 89101, United States

Location

Forest Investigative Site 048

Las Vegas, Nevada, 89101, United States

Location

Forest Investigative Site 052

Las Vegas, Nevada, 89101, United States

Location

Forest Investigative Site 014

Elizabeth, New Jersey, 27609, United States

Location

Forest Investigative Site 051

Trenton, New Jersey, 08611, United States

Location

Forest Investigative Site 003

Asheboro, North Carolina, 27203, United States

Location

Forest Investigative Site 010

Charlotte, North Carolina, 28277, United States

Location

Forest Investigative Site 011

Raleigh, North Carolina, 27609, United States

Location

Forest Investigative Site 016

Raleigh, North Carolina, 27609, United States

Location

Forest Investigative Site 005

Wilmington, North Carolina, 28401, United States

Location

Forest Investigative Site 036

Winston-Salem, North Carolina, 27103, United States

Location

Forest Investigative Site 002

Columbus, Ohio, 43213, United States

Location

Forest Investigative Site 050

Norman, Oklahoma, 73069, United States

Location

Forest Investigative Site 030

Portland, Oregon, 33709, United States

Location

Forest Investigative Site 056

Downingtown, Pennsylvania, 19335, United States

Location

Forest Investigative Site 022

Pelzer, South Carolina, 29669, United States

Location

Forest Investigative Site 053

Beaumont, Texas, 77701, United States

Location

Forest Investigative Site 066

Boerne, Texas, 78006, United States

Location

Forest Investigative Site 076

Corpus Christi, Texas, 78404, United States

Location

Forest Investigative Site 037

Dallas, Texas, 75234, United States

Location

Forest Investigative Site 043

Haltom City, Texas, 84070, United States

Location

Forest Investigative Site 015

Houston, Texas, 77081, United States

Location

Forest Investigative Site 026

Houston, Texas, 77081, United States

Location

Forest Investigative Site 027

Houston, Texas, 77081, United States

Location

Forest Investigative Site 074

Houston, Texas, 77081, United States

Location

Forest Investigative Site 071

Orem, Utah, 84058, United States

Location

Forest Investigative Site 042

Sandy City, Utah, 84070, United States

Location

Forest Investigative Site 063

Norfolk, Virginia, 23502, United States

Location

Forest Investigative Site 064

Norfolk, Virginia, 23502, United States

Location

Forest Investigative Site 046

Port Orchard, Washington, 98366, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Tatjana Lukic, MD, MSc
• Organization: Forest Research Institute

tanya.lukic@frx.com

(201) 427-8649

Study Officials

• Tatjana Lukic, MD, M. Sc.

  Forest Laboratories

  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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 12, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 16, 2013
• Results First Posted: May 16, 2013

Record last verified: 2013-03

Locations

US (75)