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

February 13, 2020 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is double blind (neither you nor the physician will know when you are receiving placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol or hydrochlorothiazide).

All participants will also receive lisinopril, an angiotensin converting enzyme, or losartan, an angiotensin receptor blocker. All medications are approved and marketed for the treatment of hypertension.This study is being conducted in about 500 patients at approximately 80 research centers in the United States.

The study consists of approximately 9 study visits over a period of 5 months. During these visits, patients will undergo routine health exams and some special laboratory tests such as an oral glucose tolerance test.

Study Type

Interventional

Enrollment (Actual)

537

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Athens, Alabama, United States, 35611
        • Forest Investigative Site 058
      • Birmingham, Alabama, United States, 35215
        • Forest Investigative Site 101
      • Huntsville, Alabama, United States, 35801
        • Forest Investigative Site 016
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Forest Investigative Site 119
      • Tucson, Arizona, United States, 85715
        • Forest Investigative Site 078
    • California
      • Anaheim, California, United States, 92801
        • Forest Investigative Site 056
      • Bell Gardens, California, United States, 90201
        • Forest Investigative Site 097
      • Buena Park, California, United States, 90620
        • Forest Investigative Site 026
      • Buena Park, California, United States, 90620
        • Forest Investigative Site 147
      • Chino, California, United States, 91710
        • Forest Investigative Site 061
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 108
      • Encinitas, California, United States, 92024
        • Forest Investigative Site 054
      • Fresno, California, United States, 93703
        • Forest Investigative Site 128
      • Huntington Park, California, United States, 90255
        • Forest Investigative Site 127
      • Long Beach, California, United States, 90806
        • Forest Investigative Site 030
      • Los Angeles, California, United States, 90057
        • Forest Investigative Site 085
      • Los Angeles, California, United States, 90211
        • Forest Investigative Site 028
      • National City, California, United States, 91950
        • Forest Investigative Site 124
      • Riverside, California, United States, 92506
        • Forest Investigative Site 117
      • Roseville, California, United States, 95661
        • Forest Investigative Site 025
      • Sacramento, California, United States, 95821
        • Forest Investigative Site 017
      • San Diego, California, United States, 92128
        • Forest Investigative Site 068
      • Santa Ana, California, United States, 92705
        • Forest Investigative Site 112
      • Temecula, California, United States, 92591
        • Forest Investigative Site 063
      • Tustin, California, United States, 92780
        • Forest Investigative Site 013
      • Walnut Creek, California, United States, 94598
        • Forest Investigative Site 052
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Forest Investigative Site 074
    • Florida
      • Brooksville, Florida, United States, 34601
        • Forest Investigative Site 139
      • Coral Gables, Florida, United States, 33134
        • Forest Investigative Site 103
      • Daytona Beach, Florida, United States, 32117
        • Forest Investigative Site 019
      • DeLand, Florida, United States, 32720
        • Forest Investigative Site 010
      • Hialeah, Florida, United States, 33012
        • Forest Investigative Site 073
      • Hialeah, Florida, United States, 33012
        • Forest Investigative Site 109
      • Hollywood, Florida, United States, 33023
        • Forest Investigative Site 036
      • Miami, Florida, United States, 33135
        • Forest Investigative Site 104
      • Miami, Florida, United States, 33143
        • Forest Investigative Site 121
      • Miami, Florida, United States, 33183
        • Forest Investigative Site 099
      • Pembroke Pines, Florida, United States, 33024
        • Forest Investigative Site 107
      • Saint Petersburg, Florida, United States, 33709
        • Forest Investigative Site 141
      • Tampa, Florida, United States, 33606
        • Forest Investigative Site 140
      • West Palm Beach, Florida, United States, 33401
        • Forest Investigative Site 060
      • West Palm Beach, Florida, United States, 33407
        • Forest Investigative Site 125
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • Forest Investigative Site 075
      • Atlanta, Georgia, United States, 30338
        • Forest Investigative Site 072
      • Augusta, Georgia, United States, 30904
        • Forest Investigative Site 042
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Forest Investigative Site 094
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Forest Investigative Site 95
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Forest Investigative Site 082
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Forest Investigative Site 096
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Forest Investigative Site 065
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Forest Investigative Site 123
    • Maine
      • Auburn, Maine, United States, 04210
        • Forest Investigative Site 106
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • Forest Investigative Site 006
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Forest Investigative Site 067
      • Brockton, Massachusetts, United States, 02301
        • Forest Investigative Site 110
    • Michigan
      • Paw Paw, Michigan, United States, 49079
        • Forest Investigative Site 018
      • Saint Clair Shores, Michigan, United States, 48081
        • Forest Investigative Site 021
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Forest Investigative Site 080
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
        • Forest Investigative Site 146
    • New York
      • Brooklyn, New York, United States, 11203
        • Forest Investigative Site 071
      • New York, New York, United States, 10001
        • Forest Investigative Site 081
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Forest Investigative Site 035
      • Charlotte, North Carolina, United States, 28262
        • Forest Investigative Site 051
      • Durham, North Carolina, United States, 27704
        • Forest Investigative Site 077
      • Lenoir, North Carolina, United States, 28645
        • Forest Investigative Site 100
      • Morehead City, North Carolina, United States, 28557
        • Forest Investigative Site 041
      • Salisbury, North Carolina, United States, 28144
        • Forest Investigative Site 050
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Forest Investigative Site 091
      • Cincinnati, Ohio, United States, 45242
        • Forest Investigative Site 089
      • Perrysburg, Ohio, United States, 43551
        • Forest Investigative Site 122
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Forest Investigative Site 087
      • Portland, Oregon, United States, 97210
        • Forest Investigative Site 088
    • Pennsylvania
      • Harleysville, Pennsylvania, United States, 19438
        • Forest Investigative Site 114
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Forest Investigative Site 083
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Forest Investigative Site 098
      • Greer, South Carolina, United States, 29651
        • Forest Investigative Site 115
      • Simpsonville, South Carolina, United States, 29201
        • Forest Investigative Site 105
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Forest Investigative Site 092
    • Texas
      • Carrollton, Texas, United States, 75006-5810
        • Forest Investigative Site 003
      • Houston, Texas, United States, 77074
        • Forest Investigative Site 116
      • Odessa, Texas, United States, 79761
        • Forest Investigative Site 120
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 012
      • Sugar Land, Texas, United States, 77479
        • Forest Investigative Site 048
    • Utah
      • Bountiful, Utah, United States, 84010-5174
        • Forest Investigative Site 040
      • Salt Lake City, Utah, United States, 84102
        • Forest Investigative Site 062
      • Salt Lake City, Utah, United States, 84102
        • Forest Investigative Site 093
      • West Jordan, Utah, United States, 84088
        • Forest Investigative Site 130
    • Virginia
      • Arlington, Virginia, United States, 22204
        • Forest Investigative Site 126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Nebivolol
Nebivolol with concomitant losartan or lisinopril
Drug: Nebivolol with concomitant losartan or lisinopril
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.
ACTIVE_COMPARATOR: Hydrochlorothiazide (HCTZ)
HCTZ with concomitant losartan or lisinopril
Drug: HCTZ with concomitant losartan or lisinopril
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.
PLACEBO_COMPARATOR: Placebo
Placebo with concomitant losartan or lisinopril
Drug: Placebo with concomitant losartan or lisinopril
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Seated Diastolic Blood Pressure
Time Frame: Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Glucose Level After an Oral Glucose Tolerance Test
Time Frame: Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)
Change from Baseline in Plasma Glucose 2 Hours Post-oral Glucose 75 grams, given as part of an Oral Glucose Tolerance Test (OGTT). Last Observation Carried Forward.
Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: John Shea, MS, Forest Research Institute, a subdisiary of Forest Laboratories, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 15, 2008

Primary Completion (ACTUAL)

July 9, 2010

Study Completion (ACTUAL)

July 9, 2010

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (ESTIMATE)

May 7, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEB-MD-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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