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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nebivolol with concomitant losartan or lisinopril
HCTZ with concomitant losartan or lisinopril
Placebo with concomitant losartan or lisinopril
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring nebivolol, BYSTOLIC ™, hydrochlorothiazide, lisinopril, Prinivil (TM), Zestril (TM), losartan, Cozaar (TM), Impaired Fasting Glucose, Impaired Glucose Tolerance, hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Forest Investigative Site 058
  • Forest Investigative Site 101
  • Forest Investigative Site 016
  • Forest Investigative Site 119
  • Forest Investigative Site 078
  • Forest Investigative Site 056
  • Forest Investigative Site 097
  • Forest Investigative Site 026
  • Forest Investigative Site 147
  • Forest Investigative Site 061
  • Forest Investigative Site 108
  • Forest Investigative Site 054
  • Forest Investigative Site 128
  • Forest Investigative Site 127
  • Forest Investigative Site 030
  • Forest Investigative Site 085
  • Forest Investigative Site 028
  • Forest Investigative Site 124
  • Forest Investigative Site 117
  • Forest Investigative Site 025
  • Forest Investigative Site 017
  • Forest Investigative Site 068
  • Forest Investigative Site 112
  • Forest Investigative Site 063
  • Forest Investigative Site 013
  • Forest Investigative Site 052
  • Forest Investigative Site 074
  • Forest Investigative Site 139
  • Forest Investigative Site 103
  • Forest Investigative Site 019
  • Forest Investigative Site 010
  • Forest Investigative Site 073
  • Forest Investigative Site 109
  • Forest Investigative Site 036
  • Forest Investigative Site 104
  • Forest Investigative Site 121
  • Forest Investigative Site 099
  • Forest Investigative Site 107
  • Forest Investigative Site 141
  • Forest Investigative Site 140
  • Forest Investigative Site 060
  • Forest Investigative Site 125
  • Forest Investigative Site 075
  • Forest Investigative Site 072
  • Forest Investigative Site 042
  • Forest Investigative Site 094
  • Forest Investigative Site 95
  • Forest Investigative Site 082
  • Forest Investigative Site 096
  • Forest Investigative Site 065
  • Forest Investigative Site 123
  • Forest Investigative Site 106
  • Forest Investigative Site 006
  • Forest Investigative Site 067
  • Forest Investigative Site 110
  • Forest Investigative Site 018
  • Forest Investigative Site 021
  • Forest Investigative Site 080
  • Forest Investigative Site 146
  • Forest Investigative Site 071
  • Forest Investigative Site 081
  • Forest Investigative Site 035
  • Forest Investigative Site 051
  • Forest Investigative Site 077
  • Forest Investigative Site 100
  • Forest Investigative Site 041
  • Forest Investigative Site 050
  • Forest Investigative Site 091
  • Forest Investigative Site 089
  • Forest Investigative Site 122
  • Forest Investigative Site 087
  • Forest Investigative Site 088
  • Forest Investigative Site 114
  • Forest Investigative Site 083
  • Forest Investigative Site 098
  • Forest Investigative Site 115
  • Forest Investigative Site 105
  • Forest Investigative Site 092
  • Forest Investigative Site 003
  • Forest Investigative Site 116
  • Forest Investigative Site 120
  • Forest Investigative Site 012
  • Forest Investigative Site 048
  • Forest Investigative Site 040
  • Forest Investigative Site 062
  • Forest Investigative Site 093
  • Forest Investigative Site 130
  • Forest Investigative Site 126

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Nebivolol

Hydrochlorothiazide (HCTZ)

Placebo

Arm Description

Nebivolol with concomitant losartan or lisinopril

HCTZ with concomitant losartan or lisinopril

Placebo with concomitant losartan or lisinopril

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Plasma Glucose Level After an Oral Glucose Tolerance Test
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.

Full Information

First Posted
April 29, 2008
Last Updated
February 13, 2020
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00673790
Brief Title
The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
Official Title
Blood Pressure and Metabolic Effects of Nebivolol Compared With Hydrochlorothiazide and Placebo in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2008 (Actual)
Primary Completion Date
July 9, 2010 (Actual)
Study Completion Date
July 9, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
nebivolol, BYSTOLIC ™, hydrochlorothiazide, lisinopril, Prinivil (TM), Zestril (TM), losartan, Cozaar (TM), Impaired Fasting Glucose, Impaired Glucose Tolerance, hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
537 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nebivolol
Arm Type
Active Comparator
Arm Description
Nebivolol with concomitant losartan or lisinopril
Arm Title
Hydrochlorothiazide (HCTZ)
Arm Type
Active Comparator
Arm Description
HCTZ with concomitant losartan or lisinopril
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo with concomitant losartan or lisinopril
Intervention Type
Drug
Intervention Name(s)
Nebivolol with concomitant losartan or lisinopril
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
HCTZ with concomitant losartan or lisinopril
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo with concomitant losartan or lisinopril
Intervention Description
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Primary Outcome Measure Information:
Title
Trough Seated Diastolic Blood Pressure
Description
Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).
Time Frame
Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)
Secondary Outcome Measure Information:
Title
Plasma Glucose Level After an Oral Glucose Tolerance Test
Description
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.
Time Frame
Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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