The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
- Conditions
- Hypertension
- Interventions
- Drug: Placebo with concomitant losartan or lisinopril
- Registration Number
- NCT00673790
- Lead Sponsor
- Forest Laboratories
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 537
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo with concomitant losartan or lisinopril Placebo with concomitant losartan or lisinopril Nebivolol Nebivolol with concomitant losartan or lisinopril Nebivolol with concomitant losartan or lisinopril Hydrochlorothiazide (HCTZ) HCTZ with concomitant losartan or lisinopril HCTZ with concomitant losartan or lisinopril
- Primary Outcome Measures
Name Time Method Trough Seated Diastolic Blood Pressure 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).
- Secondary Outcome Measures
Name Time Method 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) 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.
Trial Locations
- Locations (88)
Forest Investigative Site 117
🇺🇸Riverside, California, United States
Forest Investigative Site 072
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 006
🇺🇸Oxon Hill, Maryland, United States
Forest Investigative Site 130
🇺🇸West Jordan, Utah, United States
Forest Investigative Site 082
🇺🇸Chicago, Illinois, United States
Forest Investigative Site 112
🇺🇸Santa Ana, California, United States
Forest Investigative Site 035
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 124
🇺🇸National City, California, United States
Forest Investigative Site 123
🇺🇸Lafayette, Louisiana, United States
Forest Investigative Site 071
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 013
🇺🇸Tustin, California, United States
Forest Investigative Site 030
🇺🇸Long Beach, California, United States
Forest Investigative Site 042
🇺🇸Augusta, Georgia, United States
Forest Investigative Site 018
🇺🇸Paw Paw, Michigan, United States
Forest Investigative Site 109
🇺🇸Hialeah, Florida, United States
Forest Investigative Site 096
🇺🇸Wichita, Kansas, United States
Forest Investigative Site 108
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 085
🇺🇸Los Angeles, California, United States
Forest Investigative Site 075
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 097
🇺🇸Bell Gardens, California, United States
Forest Investigative Site 139
🇺🇸Brooksville, Florida, United States
Forest Investigative Site 028
🇺🇸Los Angeles, California, United States
Forest Investigative Site 95
🇺🇸Meridian, Idaho, United States
Forest Investigative Site 026
🇺🇸Buena Park, California, United States
Forest Investigative Site 147
🇺🇸Buena Park, California, United States
Forest Investigative Site 128
🇺🇸Fresno, California, United States
Forest Investigative Site 036
🇺🇸Hollywood, Florida, United States
Forest Investigative Site 067
🇺🇸Brockton, Massachusetts, United States
Forest Investigative Site 110
🇺🇸Brockton, Massachusetts, United States
Forest Investigative Site 107
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative Site 054
🇺🇸Encinitas, California, United States
Forest Investigative Site 065
🇺🇸Madisonville, Kentucky, United States
Forest Investigative Site 100
🇺🇸Lenoir, North Carolina, United States
Forest Investigative Site 087
🇺🇸Eugene, Oregon, United States
Forest Investigative Site 025
🇺🇸Roseville, California, United States
Forest Investigative Site 060
🇺🇸West Palm Beach, Florida, United States
Forest Investigative Site 052
🇺🇸Walnut Creek, California, United States
Forest Investigative Site 146
🇺🇸Elizabeth, New Jersey, United States
Forest Investigative Site 091
🇺🇸Centerville, Ohio, United States
Forest Investigative Site 041
🇺🇸Morehead City, North Carolina, United States
Forest Investigative Site 120
🇺🇸Odessa, Texas, United States
Forest Investigative Site 126
🇺🇸Arlington, Virginia, United States
Forest Investigative Site 040
🇺🇸Bountiful, Utah, United States
Forest Investigative Site 098
🇺🇸Columbia, South Carolina, United States
Forest Investigative Site 092
🇺🇸Sioux Falls, South Dakota, United States
Forest Investigative Site 003
🇺🇸Carrollton, Texas, United States
Forest Investigative Site 119
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 104
🇺🇸Miami, Florida, United States
Forest Investigative Site 068
🇺🇸San Diego, California, United States
Forest Investigative Site 093
🇺🇸Salt Lake City, Utah, United States
Forest Investigative Site 121
🇺🇸Miami, Florida, United States
Forest Investigative Site 077
🇺🇸Durham, North Carolina, United States
Forest Investigative Site 089
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 012
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 062
🇺🇸Salt Lake City, Utah, United States
Forest Investigative Site 101
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 088
🇺🇸Portland, Oregon, United States
Forest Investigative Site 058
🇺🇸Athens, Alabama, United States
Forest Investigative Site 016
🇺🇸Huntsville, Alabama, United States
Forest Investigative Site 140
🇺🇸Tampa, Florida, United States
Forest Investigative Site 103
🇺🇸Coral Gables, Florida, United States
Forest Investigative Site 099
🇺🇸Miami, Florida, United States
Forest Investigative Site 141
🇺🇸Saint Petersburg, Florida, United States
Forest Investigative Site 078
🇺🇸Tucson, Arizona, United States
Forest Investigative Site 061
🇺🇸Chino, California, United States
Forest Investigative Site 127
🇺🇸Huntington Park, California, United States
Forest Investigative Site 074
🇺🇸Milford, Connecticut, United States
Forest Investigative Site 063
🇺🇸Temecula, California, United States
Forest Investigative Site 019
🇺🇸Daytona Beach, Florida, United States
Forest Investigative Site 073
🇺🇸Hialeah, Florida, United States
Forest Investigative Site 010
🇺🇸DeLand, Florida, United States
Forest Investigative Site 080
🇺🇸Columbia, Missouri, United States
Forest Investigative Site 106
🇺🇸Auburn, Maine, United States
Forest Investigative Site 021
🇺🇸Saint Clair Shores, Michigan, United States
Forest Investigative Site 081
🇺🇸New York, New York, United States
Forest Investigative Site 051
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 122
🇺🇸Perrysburg, Ohio, United States
Forest Investigative Site 115
🇺🇸Greer, South Carolina, United States
Forest Investigative Site 048
🇺🇸Sugar Land, Texas, United States
Forest Investigative Site 114
🇺🇸Harleysville, Pennsylvania, United States
Forest Investigative Site 116
🇺🇸Houston, Texas, United States
Forest Investigative Site 056
🇺🇸Anaheim, California, United States
Forest Investigative Site 125
🇺🇸West Palm Beach, Florida, United States
Forest Investigative Site 050
🇺🇸Salisbury, North Carolina, United States
Forest Investigative Site 017
🇺🇸Sacramento, California, United States
Forest Investigative Site 094
🇺🇸Honolulu, Hawaii, United States
Forest Investigative Site 083
🇺🇸Pawtucket, Rhode Island, United States
Forest Investigative Site 105
🇺🇸Simpsonville, South Carolina, United States