Clinical trial NCT00673790: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: nebivolol
BYSTOLIC ™
hydrochlorothiazide
lisinopril
Prinivil (TM)
Zestril (TM)
losartan
Cozaar (TM)
Impaired Fasting Glucose
Impaired Glucose Tolerance
hypertension
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Trough Seated Diastolic Blood Pressure
timeFrame: Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)
Secondary outcomes:
measure: Plasma Glucose Level After an Oral Glucose Tolerance Test
timeFrame: Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)
Other outcomes:
Locations:
city: Athens
country: United States
facility: Forest Investigative Site 058
state: Alabama
city: Birmingham
country: United States
facility: Forest Investigative Site 101
state: Alabama
city: Huntsville
country: United States
facility: Forest Investigative Site 016
state: Alabama
city: Phoenix
country: United States
facility: Forest Investigative Site 119
state: Arizona
city: Tucson
country: United States
facility: Forest Investigative Site 078
state: Arizona
city: Anaheim
country: United States
facility: Forest Investigative Site 056
state: California
city: Bell Gardens
country: United States
facility: Forest Investigative Site 097
state: California
city: Buena Park
country: United States
facility: Forest Investigative Site 026
state: California
city: Buena Park
country: United States
facility: Forest Investigative Site 147
state: California
city: Chino
country: United States
facility: Forest Investigative Site 061
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site 108
state: California
city: Encinitas
country: United States
facility: Forest Investigative Site 054
state: California
city: Fresno
country: United States
facility: Forest Investigative Site 128
state: California
city: Huntington Park
country: United States
facility: Forest Investigative Site 127
state: California
city: Long Beach
country: United States
facility: Forest Investigative Site 030
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 085
state: California
city: Los Angeles
country: United States
facility: Forest Investigative Site 028
state: California
city: National City
country: United States
facility: Forest Investigative Site 124
state: California
city: Riverside
country: United States
facility: Forest Investigative Site 117
state: California
city: Roseville
country: United States
facility: Forest Investigative Site 025
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 017
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 068
state: California
city: Santa Ana
country: United States
facility: Forest Investigative Site 112
state: California
city: Temecula
country: United States
facility: Forest Investigative Site 063
state: California
city: Tustin
country: United States
facility: Forest Investigative Site 013
state: California
city: Walnut Creek
country: United States
facility: Forest Investigative Site 052
state: California
city: Milford
country: United States
facility: Forest Investigative Site 074
state: Connecticut
city: Brooksville
country: United States
facility: Forest Investigative Site 139
state: Florida
city: Coral Gables
country: United States
facility: Forest Investigative Site 103
state: Florida
city: Daytona Beach
country: United States
facility: Forest Investigative Site 019
state: Florida
city: DeLand
country: United States
facility: Forest Investigative Site 010
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site 073
state: Florida
city: Hialeah
country: United States
facility: Forest Investigative Site 109
state: Florida
city: Hollywood
country: United States
facility: Forest Investigative Site 036
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 104
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 121
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 099
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 107
state: Florida
city: Saint Petersburg
country: United States
facility: Forest Investigative Site 141
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 140
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 060
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 125
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 075
state: Georgia
city: Atlanta
country: United States
facility: Forest Investigative Site 072
state: Georgia
city: Augusta
country: United States
facility: Forest Investigative Site 042
state: Georgia
city: Honolulu
country: United States
facility: Forest Investigative Site 094
state: Hawaii
city: Meridian
country: United States
facility: Forest Investigative Site 95
state: Idaho
city: Chicago
country: United States
facility: Forest Investigative Site 082
state: Illinois
city: Wichita
country: United States
facility: Forest Investigative Site 096
state: Kansas
city: Madisonville
country: United States
facility: Forest Investigative Site 065
state: Kentucky
city: Lafayette
country: United States
facility: Forest Investigative Site 123
state: Louisiana
city: Auburn
country: United States
facility: Forest Investigative Site 106
state: Maine
city: Oxon Hill
country: United States
facility: Forest Investigative Site 006
state: Maryland
city: Brockton
country: United States
facility: Forest Investigative Site 067
state: Massachusetts
city: Brockton
country: United States
facility: Forest Investigative Site 110
state: Massachusetts
city: Paw Paw
country: United States
facility: Forest Investigative Site 018
state: Michigan
city: Saint Clair Shores
country: United States
facility: Forest Investigative Site 021
state: Michigan
city: Columbia
country: United States
facility: Forest Investigative Site 080
state: Missouri
city: Elizabeth
country: United States
facility: Forest Investigative Site 146
state: New Jersey
city: Brooklyn
country: United States
facility: Forest Investigative Site 071
state: New York
city: New York
country: United States
facility: Forest Investigative Site 081
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site 035
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 051
state: North Carolina
city: Durham
country: United States
facility: Forest Investigative Site 077
state: North Carolina
city: Lenoir
country: United States
facility: Forest Investigative Site 100
state: North Carolina
city: Morehead City
country: United States
facility: Forest Investigative Site 041
state: North Carolina
city: Salisbury
country: United States
facility: Forest Investigative Site 050
state: North Carolina
city: Centerville
country: United States
facility: Forest Investigative Site 091
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 089
state: Ohio
city: Perrysburg
country: United States
facility: Forest Investigative Site 122
state: Ohio
city: Eugene
country: United States
facility: Forest Investigative Site 087
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site 088
state: Oregon
city: Harleysville
country: United States
facility: Forest Investigative Site 114
state: Pennsylvania
city: Pawtucket
country: United States
facility: Forest Investigative Site 083
state: Rhode Island
city: Columbia
country: United States
facility: Forest Investigative Site 098
state: South Carolina
city: Greer
country: United States
facility: Forest Investigative Site 115
state: South Carolina
city: Simpsonville
country: United States
facility: Forest Investigative Site 105
state: South Carolina
city: Sioux Falls
country: United States
facility: Forest Investigative Site 092
state: South Dakota
city: Carrollton
country: United States
facility: Forest Investigative Site 003
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 116
state: Texas
city: Odessa
country: United States
facility: Forest Investigative Site 120
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 012
state: Texas
city: Sugar Land
country: United States
facility: Forest Investigative Site 048
state: Texas
city: Bountiful
country: United States
facility: Forest Investigative Site 040
state: Utah
city: Salt Lake City
country: United States
facility: Forest Investigative Site 062
state: Utah
city: Salt Lake City
country: United States
facility: Forest Investigative Site 093
state: Utah
city: West Jordan
country: United States
facility: Forest Investigative Site 130
state: Utah
city: Arlington
country: United States
facility: Forest Investigative Site 126
state: Virginia
Study officials:
affiliation: Forest Research Institute, a subdisiary of Forest Laboratories, Inc.
name: John Shea, MS
role: STUDY_DIRECTOR
References: