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Trial record 71 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00673790
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : September 23, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol Drug: HCTZ Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2008
Actual Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Nebivolol
Drug: Nebivolol
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration

Active Comparator: 2
HCTZ
Drug: HCTZ
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration.

Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Trough seated diastolic blood pressure (DBP) [ Time Frame: Change from Baseline To Week 12 ]

Secondary Outcome Measures :
  1. Plasma glucose level after an oral glucose tolerance test [ Time Frame: Change from Baseline To Week 12 ]
  2. Homeostasis Model Assessment of Insulin Resistance [ Time Frame: Change from Baseline To Week 12 ]
  3. Trough seated systolic blood pressure (SBP) [ Time Frame: Change from Baseline To Week 12 ]
  4. Fasting Blood Glucose [ Time Frame: Change from Baseline To Week 12 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673790


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Locations
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United States, Alabama
Forest Investigative Site 058
Athens, Alabama, United States, 35611
Forest Investigative Site 101
Birmingham, Alabama, United States, 35215
Forest Investigative Site 016
Huntsville, Alabama, United States, 35801
United States, Arizona
Forest Investigative Site 119
Phoenix, Arizona, United States, 85020
Forest Investigative Site 078
Tucson, Arizona, United States, 85715
United States, California
Forest Investigative Site 056
Anaheim, California, United States, 92801
Forest Investigative Site 097
Bell Gardens, California, United States, 90201
Forest Investigative Site 026
Buena Park, California, United States, 90620
Forest Investigative Site 147
Buena Park, California, United States, 90620
Forest Investigative Site 061
Chino, California, United States, 91710
Forest Investigative Site 108
Costa Mesa, California, United States, 92626
Forest Investigative Site 054
Encinitas, California, United States, 92024
Forest Investigative Site 128
Fresno, California, United States, 93703
Forest Investigative Site 127
Huntington Park, California, United States, 90255
Forest Investigative Site 030
Long Beach, California, United States, 90806
Forest Investigative Site 085
Los Angeles, California, United States, 90057
Forest Investigative Site 028
Los Angeles, California, United States, 90211
Forest Investigative Site 124
National City, California, United States, 91950
Forest Investigative Site 117
Riverside, California, United States, 92506
Forest Investigative Site 025
Roseville, California, United States, 95661
Forest Investigative Site 017
Sacramento, California, United States, 95821
Forest Investigative Site 068
San Diego, California, United States, 92128
Forest Investigative Site 112
Santa Ana, California, United States, 92705
Forest Investigative Site 063
Temecula, California, United States, 92591
Forest Investigative Site 013
Tustin, California, United States, 92780
Forest Investigative Site 052
Walnut Creek, California, United States, 94598
United States, Connecticut
Forest Investigative Site 074
Milford, Connecticut, United States, 06460
United States, Florida
Forest Investigative Site 139
Brooksville, Florida, United States, 34601
Forest Investigative Site 103
Coral Gables, Florida, United States, 33134
Forest Investigative Site 019
Daytona Beach, Florida, United States, 32117
Forest Investigative Site 010
DeLand, Florida, United States, 32720
Forest Investigative Site 073
Hialeah, Florida, United States, 33012
Forest Investigative Site 109
Hialeah, Florida, United States, 33012
Forest Investigative Site 036
Hollywood, Florida, United States, 33023
Forest Investigative Site 104
Miami, Florida, United States, 33135
Forest Investigative Site 121
Miami, Florida, United States, 33143
Forest Investigative Site 099
Miami, Florida, United States, 33183
Forest Investigative Site 107
Pembroke Pines, Florida, United States, 33024
Forest Investigative Site 141
St. Petersburg, Florida, United States, 33709
Forest Investigative Site 140
Tampa, Florida, United States, 33606
Forest Investigative Site 060
West Palm Beach, Florida, United States, 33401
Forest Investigative Site 125
West Palm Beach, Florida, United States, 33407
United States, Georgia
Forest Investigative Site 075
Atlanta, Georgia, United States, 30312
Forest Investigative Site 072
Atlanta, Georgia, United States, 30338
Forest Investigative Site 042
Augusta, Georgia, United States, 30904
United States, Hawaii
Forest Investigative Site 094
Honolulu, Hawaii, United States, 96814
United States, Idaho
Forest Investigative Site 95
Meridian, Idaho, United States, 83646
United States, Illinois
Forest Investigative Site 082
Chicago, Illinois, United States, 60607
United States, Kansas
Forest Investigative Site 096
Wichita, Kansas, United States, 67203
United States, Kentucky
Forest Investigative Site 065
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Forest Investigative Site 123
Lafayette, Louisiana, United States, 70503
United States, Maine
Forest Investigative Site 106
Auburn, Maine, United States, 04210
United States, Maryland
Forest Investigative Site 006
Oxon Hill, Maryland, United States, 20745
United States, Massachusetts
Forest Investigative Site 067
Brockton, Massachusetts, United States, 02301
Forest Investigative Site 110
Brockton, Massachusetts, United States, 02301
United States, Michigan
Forest Investigative Site 018
Paw Paw, Michigan, United States, 49079
Forest Investigative Site 021
St. Clair Shores, Michigan, United States, 48081
United States, Missouri
Forest Investigative Site 080
Columbia, Missouri, United States, 65212
United States, New Jersey
Forest Investigative Site 146
Elizabeth, New Jersey, United States, 07202
United States, New York
Forest Investigative Site 071
Brooklyn, New York, United States, 11203
Forest Investigative Site 081
New York, New York, United States, 10001
United States, North Carolina
Forest Investigative Site 035
Charlotte, North Carolina, United States, 28209
Forest Investigative Site 051
Charlotte, North Carolina, United States, 28262
Forest Investigative Site 077
Durham, North Carolina, United States, 27704
Forest Investigative Site 100
Lenoir, North Carolina, United States, 28645
Forest Investigative Site 041
Morehead City, North Carolina, United States, 28557
Forest Investigative Site 050
Salisbury, North Carolina, United States, 28144
United States, Ohio
Forest Investigative Site 091
Centerville, Ohio, United States, 45459
Forest Investigative Site 089
Cincinnati, Ohio, United States, 45242
Forest Investigative Site 122
Perrysburg, Ohio, United States, 43551
United States, Oregon
Forest Investigative Site 087
Eugene, Oregon, United States, 97404
Forest Investigative Site 088
Portland, Oregon, United States, 97210
United States, Pennsylvania
Forest Investigative Site 114
Harleysville, Pennsylvania, United States, 19438
United States, Rhode Island
Forest Investigative Site 083
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Forest Investigative Site 098
Columbia, South Carolina, United States, 29201
Forest Investigative Site 115
Greer, South Carolina, United States, 29651
Forest Investigative Site 105
Simpsonville, South Carolina, United States, 29201
United States, South Dakota
Forest Investigative Site 092
Sioux Falls, South Dakota, United States, 57104
United States, Texas
Forest Investigative Site 003
Carrollton, Texas, United States, 75006-5810
Forest Investigative Site 116
Houston, Texas, United States, 77074
Forest Investigative Site 120
Odessa, Texas, United States, 79761
Forest Investigative Site 012
San Antonio, Texas, United States, 78229
Forest Investigative Site 048
Sugar Land, Texas, United States, 77479
United States, Utah
Forest Investigative Site 040
Bountiful, Utah, United States, 84010-5174
Forest Investigative Site 062
Salt Lake City, Utah, United States, 84102
Forest Investigative Site 093
Salt Lake City, Utah, United States, 84102
Forest Investigative Site 130
West Jordan, Utah, United States, 84088
United States, Virginia
Forest Investigative Site 126
Arlington, Virginia, United States, 22204
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: John Shea, MS Forest Research Institute, a subdisiary of Forest Laboratories, Inc.

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Responsible Party: John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a subsidiary of Forest Laboratories Inc.
ClinicalTrials.gov Identifier: NCT00673790     History of Changes
Other Study ID Numbers: NEB-MD-04
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: September 23, 2010
Last Verified: September 2010
Keywords provided by Forest Laboratories:
hydrochlorothiazide
losartan
Cozaar (TM)
nebivolol
BYSTOLIC ™
lisinopril
Prinivil (TM)
Zestril (TM)
Impaired Fasting Glucose
Impaired Glucose Tolerance
hypertension
Additional relevant MeSH terms:
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Hydrochlorothiazide
Hypertension
Glucose Intolerance
Vascular Diseases
Cardiovascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Nebivolol
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents