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The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
This study is currently recruiting participants.
Verified by Forest Laboratories, October 2009
First Received: April 29, 2008   Last Updated: October 28, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Trough seated diastolic blood pressure (DBP) [ Time Frame: Change from Baseline To Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose level after an oral glucose tolerance test [ Time Frame: Change from Baseline To Week 12 ] [ Designated as safety issue: No ]
  • Homeostasis Model Assessment of Insulin Resistance [ Time Frame: Change from Baseline To Week 12 ] [ Designated as safety issue: No ]
  • Trough seated systolic blood pressure (SBP) [ Time Frame: Change from Baseline To Week 12 ] [ Designated as safety issue: No ]
  • Fasting Blood Glucose [ Time Frame: Change from Baseline To Week 12 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673790

Contacts
Contact: Sandra Beaird, PharmD 800/678/1605 ext 66297 info@forestpharm.com

  Hide Study Locations
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
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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
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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
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Honolulu, Hawaii, United States, 96814
United States, Idaho
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Meridian, Idaho, United States, 83646
United States, Illinois
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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
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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
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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
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Sioux Falls, South Dakota, United States, 57104
United States, Texas
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San Antonio, Texas, United States, 78229
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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
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Kati Gutierrez, PharmD, PhD Forest Research Institute, a subdisiary of Forest Laboratories, Inc.
  More Information

No publications provided

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

Keywords provided by Forest Laboratories:
nebivolol
BYSTOLIC ™
hydrochlorothiazide
lisinopril
Prinivil (TM)
Zestril (TM)
losartan
Cozaar (TM)
Impaired Fasting Glucose
Impaired Glucose Tolerance
hypertension

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009