Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients

NCT00734630 | Completed Phase 4 Results

• 1 other identifier: NEB-MD-11
• Study Type: interventional
• Target: 491
• Locations: 1 country
• Sites: 75

Brief Summary

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

Conditions

Hypertension

Keywords

nebivolol; Bystolic ™; lisinopril; losartan; Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12

  Change from Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) at Week 12, Last Observation Carried Forward (LOCF).

  From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

Secondary Outcomes (1)

• Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12

  From baseline Visit 5 (Week 0) to Visit 10 (Week 12)

Study Arms (2)

Nebivolol

ACTIVE COMPARATOR

Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration

Drug: nebivolol

Placebo

PLACEBO COMPARATOR

Matching placebo tablets, oral administration

Drug: Placebo

Interventions

nebivolol DRUG

Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

Also known as: Bystolic ™

Nebivolol

Placebo DRUG

Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

Also known as: Lisinopril-other names: Prinivil, Zestril, Losartan-other name: Cozaar

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ambulatory outpatients 18-85 years old at screening
• Have a history of hypertension
• Qualifying laboratory results

You may not qualify if:

• Severe hypertension, including chronic kidney disease
• Documented congestive heart failure
• Have clinically significant respiratory, liver, or heart disease
• History of stroke, heart attack, or heart surgery in the last 6 months
• Have a history of hypersensitivity to nebivolol or other beta blockers.

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (75)

Forest Investigative Site 070

Gulf Shores, Alabama, 36535, United States

Location

Forest Investigative Site 092

Huntsville, Alabama, 35801, United States

Location

Forest Investigative Site 058

Mesa, Arizona, 85206, United States

Location

Forest Investigative Site 059

Tempe, Arizona, 85282, United States

Location

Forest Investigative Site 024

Anaheim, California, 92801, United States

Location

Forest Investigative Site 012

Bell Gardens, California, 90201, United States

Location

Forest Investigative Site 026

Chino, California, 91710, United States

Location

Forest Investigative Site 083

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 030

Los Angeles, California, 90057, United States

Location

Forest Investigative Site 053

Orange, California, 92868, United States

Location

Forest Investigative Site 077

Riverside, California, 92506, United States

Location

Forest Investigative Site 034

Sacramento, California, 95816, United States

Location

Forest Investigative Site 028

Sacramento, California, 95831, United States

Location

Forest Investigative Site 048

San Bernardino, California, 92404, United States

Location

Forest Investigative Site 075

Santa Ana, California, 92705, United States

Location

Forest Investigative Site 087

Santa Ana, California, 92705, United States

Location

Forest Investigative Site 090

Temecula, California, 92591, United States

Location

Forest Investigative Site 010

Tustin, California, 92780, United States

Location

Forest Investigative Site 001

Westlake Village, California, 91361, United States

Location

Forest Investigative Site 061

Wheat Ridge, Colorado, 80033, United States

Location

Forest Investigative Site 046

Brooksville, Florida, 34613, United States

Location

Forest Investigative Site 015

DeLand, Florida, 32720, United States

Location

Forest Investigative Site 035

Fort Lauderdale, Florida, 33306, United States

Location

Forest Investigative Site 009

Hialeah, Florida, 33012, United States

Location

Forest Investigative Site 039

Hollywood, Florida, 33021, United States

Location

Forest Investigative Site 044

Jacksonville, Florida, 32223, United States

Location

Forest Investigative Site 002

Miami, Florida, 33135, United States

Location

Forest Investigative Site 085

Miami, Florida, 33143, United States

Location

Forest Investigative Site 091

Miami, Florida, 33144, United States

Location

Forest Investigative Site 013

Miami, Florida, 33169, United States

Location

Forest Investigative Site 052

Miami, Florida, 33186, United States

Location

Forest Investigative Site 049

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 065

Pembroke Pines, Florida, 33024, United States

Location

Forest Investigative Site 041

Tampa, Florida, 33603, United States

Location

Forest Investigative Site 029

Atlanta, Georgia, 30338, United States

Location

Forest Investigative Site 068

Decatur, Georgia, 30034, United States

Location

Forest Investigative Site 050

Addison, Illinois, 60101, United States

Location

Forest Investigative Site 025

Chicago, Illinois, 60607, United States

Location

Forest Investigative Site 057

Chicago, Illinois, 60611, United States

Location

Forest Investigative Site 076

Joliet, Illinois, 60435, United States

Location

Forest Investigative Site 014

Orland Park, Illinois, 60467, United States

Location

Forest Investigative Site 079

Overland Park, Kansas, 66215, United States

Location

Forest Investigative Site 037

Auburn, Maine, 04210, United States

Location

Forest Investigative Site 045

Biddeford, Maine, 04005, United States

Location

Forest Investigative Site 003

Oxon Hill, Maryland, 20745, United States

Location

Forest Investigative Site 060

Prince Frederick, Maryland, 20678, United States

Location

Forest Investigative Site 042

Reisterstown, Maryland, 21136, United States

Location

Forest Investigative Site 023

Brockton, Massachusetts, 02301, United States

Location

Forest Investigative Site 066

Brockton, Massachusetts, 02301, United States

Location

Forest Investigative Site 040

Saint Clair Shores, Michigan, 48081, United States

Location

Forest Investigative Site 067

Rolling Fork, Mississippi, 39159, United States

Location

Forest Investigative Site 051

Edison, New Jersey, 08817, United States

Location

Forest Investigative Site 088

New York, New York, 10010, United States

Location

Forest Investigative Site 086

Syracuse, New York, 13210, United States

Location

Forest Investigative Site 006

Cary, North Carolina, 27518, United States

Location

Forest Investigative Site 022

Charlotte, North Carolina, 28209, United States

Location

Forest Investigative Site 064

Harrisburg, North Carolina, 28075, United States

Location

Forest Investigative Site 071

Raleigh, North Carolina, 27612, United States

Location

Forest Investigative Site 017

Wilmington, North Carolina, 28401, United States

Location

Forest Investigative Site 055

Fargo, North Dakota, 58104, United States

Location

Forest Investigative Site 007

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site 054

Cleveland, Ohio, 44122, United States

Location

Forest Investigative Site 056

Perrysburg, Ohio, 43551, United States

Location

Forest Investigative Site 080

Ashland, Oregon, 97520, United States

Location

Forest Investigative Site 033

Eugene, Oregon, 97404, United States

Location

Forest Investigative Site 081

Harleysville, Pennsylvania, 19438, United States

Location

Forest Investigative Site 004

Greenville, South Carolina, 29615, United States

Location

Forest Investigative Site 031

Mt. Pleasant, South Carolina, 29464, United States

Location

Forest Investigative Site 018

Cleveland, Tennessee, 37312, United States

Location

Forest Investigative Site 043

Memphis, Tennessee, 38819, United States

Location

Forest Investigative Site 032

Nashville, Tennessee, 37203, United States

Location

Forest Investigative Site 008

Corpus Christi, Texas, 78404, United States

Location

Forest Investigative Site 063

San Antonio, Texas, 78205, United States

Location

Forest Investigative Site 062

San Antonio, Texas, 78209, United States

Location

Forest Investigative Site 016

Richmond, Virginia, 23294, United States

Location

Related Publications (1)

• Weiss RJ, Stapff M, Lin Y. Placebo effect and efficacy of nebivolol in patients with hypertension not controlled with lisinopril or losartan: a phase IV, randomized, placebo-controlled trial. Am J Cardiovasc Drugs. 2013 Apr;13(2):129-40. doi: 10.1007/s40256-013-0010-y.

  PMID: 23519546 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol; Lisinopril

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; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Noah Rosenberg , MD, Exec. Dir, Clin Dev, Cardiovascular and Metabolism
• Organization: Forest Laboratories, Inc.

noah.rosenberg@frx.com

2014278000

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

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 26, 2011
• Results First Posted: April 26, 2011

Record last verified: 2011-03

Locations

US (75)