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| Sponsor: | Forest Laboratories |
|---|---|
| Information provided by: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT00673790 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Nebivolol Drug: HCTZ Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 500 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Nebivolol
|
Drug: Nebivolol
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration
|
|
2: Active Comparator
HCTZ
|
Drug: HCTZ
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration.
|
|
3: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sandra Beaird, PharmD | 800/678/1605 ext 66297 | info@forestpharm.com |
Hide Study Locations| United States, Alabama | |
| Forest Investigative Site | Withdrawn |
| Athens, Alabama, United States, 35611 | |
| Forest Investigative Site | Recruiting |
| Huntsville, Alabama, United States, 35801 | |
| Forest Investigative Site 101 | Recruiting |
| Birmingham, Alabama, United States, 35215 | |
| United States, Arizona | |
| Forest Investigative Site | Withdrawn |
| Tucson, Arizona, United States, 85715 | |
| Forest Investigative Site 119 | Recruiting |
| Phoenix, Arizona, United States, 85020 | |
| United States, California | |
| Forest Investigative Site | Recruiting |
| Buena Park, California, United States, 90620 | |
| Forest Investigative Site | Recruiting |
| Long Beach, California, United States, 90806 | |
| Forest Investigative Site | Recruiting |
| Walnut Creek, California, United States, 94598 | |
| Forest Investigative Site | Withdrawn |
| Los Angeles, California, United States, 90211 | |
| Forest Investigative Site | Withdrawn |
| Los Angeles, California, United States, 90057 | |
| Forest Investigative Site | Recruiting |
| Tustin, California, United States, 92780 | |
| Forest Investigative Site | Recruiting |
| Encinitas, California, United States, 92024 | |
| Forest Investigative Site | Recruiting |
| Temecula, California, United States, 92591 | |
| Forest Investigative Site 128 | Recruiting |
| Fresno, California, United States, 93703 | |
| Forest Investigative Site | Withdrawn |
| Roseville, California, United States, 95661 | |
| Forest Investigative Site | Withdrawn |
| Carmichael, California, United States, 95608 | |
| Forest Investigative Site | Recruiting |
| Chino, California, United States, 91710 | |
| Forest Investigative Site | Recruiting |
| San Diego, California, United States, 92128 | |
| Forest Investigative Site 017 | Recruiting |
| Sacramento, California, United States, 95821 | |
| Forest Investigative Site 097 | Recruiting |
| Bell Gardens, California, United States, 90201 | |
| Forest Investigative Site 108 | Recruiting |
| Costa Mesa, California, United States, 92626 | |
| Forest Investigative Site 112 | Recruiting |
| Santa Ana, California, United States, 92705 | |
| Forest Investigative Site 117 | Recruiting |
| Riverside, California, United States, 92506 | |
| Forest Investigative Site 124 | Recruiting |
| National City, California, United States, 91950 | |
| Forest Investigative Site 127 | Recruiting |
| Huntington Park, California, United States, 90255 | |
| Forest Investigative Site | Recruiting |
| Anaheim, California, United States, 92801 | |
| Forest Investigative Site 132 | Recruiting |
| Orange, California, United States, 92868 | |
| Forest Investigative Site 135 | Recruiting |
| Long Beach, California, United States, 90808 | |
| United States, Connecticut | |
| Forest Investigative Site | Withdrawn |
| Milford, Connecticut, United States, 06460 | |
| United States, Florida | |
| Forest Investigative Site | Withdrawn |
| Holly Hill, Florida, United States, 32117 | |
| Forest Investigative Site | Recruiting |
| DeLand, Florida, United States, 32720 | |
| Forest Investigative Site | Recruiting |
| West Palm Beach, Florida, United States, 33401 | |
| Forest Investigative Site | Recruiting |
| Hollywood, Florida, United States, 33023 | |
| Forest Investigative Site 121 | Recruiting |
| Miami, Florida, United States, 33143 | |
| Forest Investigative Site 099 | Recruiting |
| Miami, Florida, United States, 33183 | |
| Forest Investigative Site 103 | Recruiting |
| Coral Gables, Florida, United States, 33134 | |
| Forest Investigative Site 104 | Recruiting |
| Miami, Florida, United States, 33135 | |
| Forest Investigative Site 107 | Recruiting |
| Pembroke Pines, Florida, United States, 33024 | |
| Forest Investigative Site | Recruiting |
| Hialeah, Florida, United States, 33012 | |
| Forest Investigative Site 125 | Recruiting |
| West Palm Beach, Florida, United States, 33407 | |
| Forest Investigative Site 139 | Recruiting |
| Brooksville, Florida, United States, 34601 | |
| Forest Investigative Site 140 | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Forest Investigative Site 141 | Recruiting |
| St. Petersburg, Florida, United States, 33709 | |
| Forest Investigative Site 144 | Recruiting |
| Miami, Florida, United States, 33180 | |
| United States, Georgia | |
| Forest Investigative Site | Recruiting |
| Augusta, Georgia, United States, 30904 | |
| Forest Investigative Site | Active, not recruiting |
| Atlanta, Georgia, United States, 30312 | |
| Forest Investigative Site | Recruiting |
| Atlanta, Georgia, United States, 30338 | |
| Forest Investigative Site 143 | Recruiting |
| Waycross, Georgia, United States, 31501 | |
| United States, Hawaii | |
| Forest Investigative Site | Recruiting |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Idaho | |
| Forest Investigative Site | Recruiting |
| Meridian, Idaho, United States, 83646 | |
| United States, Illinois | |
| Forest Investigative Site | Recruiting |
| Chicago, Illinois, United States, 60607 | |
| United States, Kansas | |
| Forest Investigative Site 096 | Recruiting |
| Wichita, Kansas, United States, 67203 | |
| Forest Investigative Site 145 | Recruiting |
| Lansing, Kansas, United States, 66043 | |
| United States, Kentucky | |
| Forest Investigative Site | Withdrawn |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Louisiana | |
| Forest Investigative Site 123 | Recruiting |
| Lafayette, Louisiana, United States, 70503 | |
| United States, Maine | |
| Forest Investigative Site 106 | Recruiting |
| Auburn, Maine, United States, 04210 | |
| United States, Maryland | |
| Forest Investigative Site | Recruiting |
| Oxon Hill, Maryland, United States, 20745 | |
| United States, Massachusetts | |
| Forest Investigative Site 067 | Recruiting |
| Brockton, Massachusetts, United States, 02301 | |
| Forest Investigative Site 110 | Recruiting |
| Brockton, Massachusetts, United States, 02301 | |
| United States, Michigan | |
| Forest Investigative Site | Recruiting |
| Paw Paw, Michigan, United States, 49079 | |
| Forest Investigative Site | Withdrawn |
| St. Clair Shores, Michigan, United States, 48081 | |
| Forest Investigative Site 136 | Recruiting |
| Bay City, Michigan, United States, 48706 | |
| United States, Nevada | |
| Forest Investigative Site | Withdrawn |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Jersey | |
| Forest Investigative Site 146 | Recruiting |
| Elizabeth, New Jersey, United States, 07202 | |
| United States, New York | |
| Forest Investigative Site | Withdrawn |
| East Syracuse, New York, United States, 13057 | |
| Forest Investigative Site | Withdrawn |
| New York, New York, United States, 10004 | |
| Forest Investigative Site | Withdrawn |
| Bronx, New York, United States, 10468 | |
| Forest Investigative Site | Recruiting |
| New York, New York, United States, 10001 | |
| Forest Investigative Site | Recruiting |
| Brooklyn, New York, United States, 11203 | |
| Forest Investigative Site 118 | Active, not recruiting |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Forest Investigative Site | Withdrawn |
| Charlotte, North Carolina, United States, 28207 | |
| Forest Investigative Site | Recruiting |
| Salisbury, North Carolina, United States, 28144 | |
| Forest Investigative Site | Withdrawn |
| Charlotte, North Carolina, United States, 28262 | |
| Forest Investigative Site 131 | Recruiting |
| Burlington, North Carolina, United States, 27215 | |
| Forest Investigative Site | Withdrawn |
| High Point, North Carolina, United States, 27262 | |
| Forest Investigative Site | Withdrawn |
| Durham, North Carolina, United States, 27704 | |
| Forest Investigative Site | Recruiting |
| Charlotte, North Carolina, United States, 28209 | |
| Forest Investigative Site 100 | Recruiting |
| Lenoir, North Carolina, United States, 28645 | |
| Forest Investigative Site | Recruiting |
| Morehead City, North Carolina, United States, 28557 | |
| United States, Ohio | |
| Forest Investigative Site | Recruiting |
| Cincinnati, Ohio, United States, 45242 | |
| Forest Investigative Site | Recruiting |
| Centerville, Ohio, United States, 45459 | |
| Forest Investigative Site 122 | Recruiting |
| Perrysburg, Ohio, United States, 43551 | |
| Forest Investigative Site 134 | Recruiting |
| Delaware, Ohio, United States, 43015 | |
| Forest Investigative Site 142 | Recruiting |
| Cleveland, Ohio, United States, 44113 | |
| United States, Oregon | |
| Forest Investigative Site | Recruiting |
| Portland, Oregon, United States, 97210 | |
| Forest Investigative Site | Recruiting |
| Eugene, Oregon, United States, 97404 | |
| United States, Pennsylvania | |
| Forest Investigative Site 114 | Recruiting |
| Harleysville, Pennsylvania, United States, 19438 | |
| United States, Rhode Island | |
| Forest Investigative Site | Recruiting |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, South Carolina | |
| Forest Investigative Site 098 | Recruiting |
| Columbia, South Carolina, United States, 29201 | |
| Forest Investigative Site 105 | Recruiting |
| Simpsonville, South Carolina, United States, 29201 | |
| Forest Investigative Site 115 | Recruiting |
| Greer, South Carolina, United States, 29651 | |
| United States, South Dakota | |
| Forest Investigative Site | Recruiting |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Texas | |
| Forest Investigative Site | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Forest Investigative Site | Recruiting |
| Carrollton, Texas, United States, 75006-5810 | |
| Forest Investigative Site 048 | Recruiting |
| Sugar Land, Texas, United States, 77479 | |
| Forest Investigative Site 116 | Recruiting |
| Houston, Texas, United States, 77074 | |
| Forest Investigative Site 120 | Recruiting |
| Odessa, Texas, United States, 79761 | |
| United States, Utah | |
| Forest Investigative Site 062 | Recruiting |
| Salt Lake City, Utah, United States, 84102 | |
| Forest Investigative Site | Recruiting |
| Bountiful, Utah, United States, 84010-5174 | |
| Forest Investigative Site 093 | Recruiting |
| Salt Lake City, Utah, United States, 84102 | |
| Forest Investigative Site 130 | Recruiting |
| West Jordan, Utah, United States, 84088 | |
| United States, Virginia | |
| Forest Investigative Site 126 | Recruiting |
| Arlington, Virginia, United States, 22204 | |
| Forest Investigative Site 133 | Recruiting |
| Newport News, Virginia, United States, 23606 | |
| United States, Washington | |
| Forest Investigative Site 137 | Active, not recruiting |
| Spokane, Washington, United States, 99216 | |
| United States, Wisconsin | |
| Forest Investigative Site 129 | Recruiting |
| Green Bay, Wisconsin, United States, 54303 | |
| Study Director: | Kati Gutierrez, PharmD, PhD | Forest Research Institute, a subdisiary of Forest Laboratories, Inc. |
More Information
| Responsible Party: | Forest Research Institute, a subsidiary of Forest Laboratories Inc. ( John Whalen, MD, Executive Director, Clinical Development, Cardiovascular ) |
| Study ID Numbers: | NEB-MD-04 |
| Study First Received: | April 29, 2008 |
| Last Updated: | October 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00673790 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
nebivolol BYSTOLIC ™ hydrochlorothiazide lisinopril Prinivil (TM) Zestril (TM) |
losartan Cozaar (TM) Impaired Fasting Glucose Impaired Glucose Tolerance hypertension |
|
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Prediabetic State Membrane Transport Modulators Hyperglycemia Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Metabolic Diseases |
Glucose Intolerance Diabetes Mellitus Vascular Diseases Nebivolol Endocrine System Diseases Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide Pharmacologic Actions Natriuretic Agents Adrenergic Antagonists Glucose Metabolism Disorders Hypertension |