The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose

NCT00673790 | Completed Phase 4 Results

• 1 other identifier: NEB-MD-04
• Study Type: interventional
• Target: 537
• Locations: 1 country
• Sites: 88

Brief Summary

This study is being done to see if the blood pressure and metabolic effects of an approved drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and placebo in hypertensive patients.

Conditions

Hypertension

Keywords

nebivolol; BYSTOLIC ™; hydrochlorothiazide; lisinopril; Prinivil (TM); Zestril (TM); losartan; Cozaar (TM); Impaired Fasting Glucose; Impaired Glucose Tolerance; hypertension

Outcome Measures

Primary Outcomes (1)

• Trough Seated Diastolic Blood Pressure

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

  Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)

Secondary Outcomes (1)

• Plasma Glucose Level After an Oral Glucose Tolerance Test

  Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)

Study Arms (3)

Nebivolol

ACTIVE COMPARATOR

Nebivolol with concomitant losartan or lisinopril

Drug: Nebivolol with concomitant losartan or lisinopril

Hydrochlorothiazide (HCTZ)

ACTIVE COMPARATOR

HCTZ with concomitant losartan or lisinopril

Drug: HCTZ with concomitant losartan or lisinopril

Placebo

PLACEBO COMPARATOR

Placebo with concomitant losartan or lisinopril

Drug: Placebo with concomitant losartan or lisinopril

Interventions

Nebivolol with concomitant losartan or lisinopril DRUG

Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.

Nebivolol

HCTZ with concomitant losartan or lisinopril DRUG

Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.

Hydrochlorothiazide (HCTZ)

Placebo with concomitant losartan or lisinopril DRUG

Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ambulatory outpatients 18-80 years old at screening.
• Have a history of hypertension and taking up to 2 medications for high blood pressure.
• Qualifying laboratory results confirming impaired fasting glucose or impaired glucose tolerance
• Vision and hearing (hearing aid permissible) sufficient for compliance with questionnaire completion

You may not qualify if:

• Have clinically significant respiratory, liver or cardiovascular disease
• Presence of coronary artery disease requiring treatment with a beat blocker, calcium channel blocker or nitrates
• Use of niacin or antidiabetic drugs (oral or injectable) within 6 months before study entry
• Have a history of hypersensitivity to nebivolol, other beta-blockers, hydrochlorothiazide, or other sulfonamide-derived drugs.

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (88)

Forest Investigative Site 058

Athens, Alabama, 35611, United States

Location

Forest Investigative Site 101

Birmingham, Alabama, 35215, United States

Location

Forest Investigative Site 016

Huntsville, Alabama, 35801, United States

Location

Forest Investigative Site 119

Phoenix, Arizona, 85020, United States

Location

Forest Investigative Site 078

Tucson, Arizona, 85715, United States

Location

Forest Investigative Site 056

Anaheim, California, 92801, United States

Location

Forest Investigative Site 097

Bell Gardens, California, 90201, United States

Location

Forest Investigative Site 026

Buena Park, California, 90620, United States

Location

Forest Investigative Site 147

Buena Park, California, 90620, United States

Location

Forest Investigative Site 061

Chino, California, 91710, United States

Location

Forest Investigative Site 108

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 054

Encinitas, California, 92024, United States

Location

Forest Investigative Site 128

Fresno, California, 93703, United States

Location

Forest Investigative Site 127

Huntington Park, California, 90255, United States

Location

Forest Investigative Site 030

Long Beach, California, 90806, United States

Location

Forest Investigative Site 085

Los Angeles, California, 90057, United States

Location

Forest Investigative Site 028

Los Angeles, California, 90211, United States

Location

Forest Investigative Site 124

National City, California, 91950, United States

Location

Forest Investigative Site 117

Riverside, California, 92506, United States

Location

Forest Investigative Site 025

Roseville, California, 95661, United States

Location

Forest Investigative Site 017

Sacramento, California, 95821, United States

Location

Forest Investigative Site 068

San Diego, California, 92128, United States

Location

Forest Investigative Site 112

Santa Ana, California, 92705, United States

Location

Forest Investigative Site 063

Temecula, California, 92591, United States

Location

Forest Investigative Site 013

Tustin, California, 92780, United States

Location

Forest Investigative Site 052

Walnut Creek, California, 94598, United States

Location

Forest Investigative Site 074

Milford, Connecticut, 06460, United States

Location

Forest Investigative Site 139

Brooksville, Florida, 34601, United States

Location

Forest Investigative Site 103

Coral Gables, Florida, 33134, United States

Location

Forest Investigative Site 019

Daytona Beach, Florida, 32117, United States

Location

Forest Investigative Site 010

DeLand, Florida, 32720, United States

Location

Forest Investigative Site 073

Hialeah, Florida, 33012, United States

Location

Forest Investigative Site 109

Hialeah, Florida, 33012, United States

Location

Forest Investigative Site 036

Hollywood, Florida, 33023, United States

Location

Forest Investigative Site 104

Miami, Florida, 33135, United States

Location

Forest Investigative Site 121

Miami, Florida, 33143, United States

Location

Forest Investigative Site 099

Miami, Florida, 33183, United States

Location

Forest Investigative Site 107

Pembroke Pines, Florida, 33024, United States

Location

Forest Investigative Site 141

St. Petersburg, Florida, 33709, United States

Location

Forest Investigative Site 140

Tampa, Florida, 33606, United States

Location

Forest Investigative Site 060

West Palm Beach, Florida, 33401, United States

Location

Forest Investigative Site 125

West Palm Beach, Florida, 33407, United States

Location

Forest Investigative Site 075

Atlanta, Georgia, 30312, United States

Location

Forest Investigative Site 072

Atlanta, Georgia, 30338, United States

Location

Forest Investigative Site 042

Augusta, Georgia, 30904, United States

Location

Forest Investigative Site 094

Honolulu, Hawaii, 96814, United States

Location

Forest Investigative Site 95

Meridian, Idaho, 83646, United States

Location

Forest Investigative Site 082

Chicago, Illinois, 60607, United States

Location

Forest Investigative Site 096

Wichita, Kansas, 67203, United States

Location

Forest Investigative Site 065

Madisonville, Kentucky, 42431, United States

Location

Forest Investigative Site 123

Lafayette, Louisiana, 70503, United States

Location

Forest Investigative Site 106

Auburn, Maine, 04210, United States

Location

Forest Investigative Site 006

Oxon Hill, Maryland, 20745, United States

Location

Forest Investigative Site 067

Brockton, Massachusetts, 02301, United States

Location

Forest Investigative Site 110

Brockton, Massachusetts, 02301, United States

Location

Forest Investigative Site 018

Paw Paw, Michigan, 49079, United States

Location

Forest Investigative Site 021

Saint Clair Shores, Michigan, 48081, United States

Location

Forest Investigative Site 080

Columbia, Missouri, 65212, United States

Location

Forest Investigative Site 146

Elizabeth, New Jersey, 07202, United States

Location

Forest Investigative Site 071

Brooklyn, New York, 11203, United States

Location

Forest Investigative Site 081

New York, New York, 10001, United States

Location

Forest Investigative Site 035

Charlotte, North Carolina, 28209, United States

Location

Forest Investigative Site 051

Charlotte, North Carolina, 28262, United States

Location

Forest Investigative Site 077

Durham, North Carolina, 27704, United States

Location

Forest Investigative Site 100

Lenoir, North Carolina, 28645, United States

Location

Forest Investigative Site 041

Morehead City, North Carolina, 28557, United States

Location

Forest Investigative Site 050

Salisbury, North Carolina, 28144, United States

Location

Forest Investigative Site 091

Centerville, Ohio, 45459, United States

Location

Forest Investigative Site 089

Cincinnati, Ohio, 45242, United States

Location

Forest Investigative Site 122

Perrysburg, Ohio, 43551, United States

Location

Forest Investigative Site 087

Eugene, Oregon, 97404, United States

Location

Forest Investigative Site 088

Portland, Oregon, 97210, United States

Location

Forest Investigative Site 114

Harleysville, Pennsylvania, 19438, United States

Location

Forest Investigative Site 083

Pawtucket, Rhode Island, 02860, United States

Location

Forest Investigative Site 098

Columbia, South Carolina, 29201, United States

Location

Forest Investigative Site 115

Greer, South Carolina, 29651, United States

Location

Forest Investigative Site 105

Simpsonville, South Carolina, 29201, United States

Location

Forest Investigative Site 092

Sioux Falls, South Dakota, 57104, United States

Location

Forest Investigative Site 003

Carrollton, Texas, 75006-5810, United States

Location

Forest Investigative Site 116

Houston, Texas, 77074, United States

Location

Forest Investigative Site 120

Odessa, Texas, 79761, United States

Location

Forest Investigative Site 012

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 048

Sugar Land, Texas, 77479, United States

Location

Forest Investigative Site 040

Bountiful, Utah, 84010-5174, United States

Location

Forest Investigative Site 062

Salt Lake City, Utah, 84102, United States

Location

Forest Investigative Site 093

Salt Lake City, Utah, 84102, United States

Location

Forest Investigative Site 130

West Jordan, Utah, 84088, United States

Location

Forest Investigative Site 126

Arlington, Virginia, 22204, United States

Location

MeSH Terms

Conditions

Hypertension; Glucose Intolerance

Interventions

Nebivolol; Lisinopril; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic 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; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• John Shea, MS

  Forest Research Institute, a subdisiary 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: April 29, 2008
• First Posted: May 7, 2008
• Study Start: May 15, 2008
• Primary Completion: July 9, 2010
• Study Completion: July 9, 2010
• Last Updated: February 26, 2020
• Results First Posted: February 26, 2020

Record last verified: 2020-02

Locations

US (88)