The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
NCT ID: NCT00673790
Last Updated: 2020-02-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
537 participants
INTERVENTIONAL
2008-05-15
2010-07-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab
NCT01076140
Ertugliflozin Versus Hydrochlorothiazide in Reducing Sympathetic Neural Overactivity in Patients With Hypertension and Recently-diagnosed Type 2 Diabetes.
NCT03640221
The Effects of Nebivolol on the NO-system in Patients With Essential Hypertension
NCT01679652
Effects of Thiazide Diuretics on Sympathetic Nervous System in Hypertension
NCT00353652
The Hypotensive Effect of Metformin in Hypertensive Patients.
NCT02072382
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nebivolol
Nebivolol with concomitant losartan or lisinopril
Nebivolol with concomitant losartan or lisinopril
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Hydrochlorothiazide (HCTZ)
HCTZ with concomitant losartan or lisinopril
HCTZ with concomitant losartan or lisinopril
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Placebo
Placebo with concomitant losartan or lisinopril
Placebo with concomitant losartan or lisinopril
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nebivolol with concomitant losartan or lisinopril
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
HCTZ with concomitant losartan or lisinopril
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Placebo with concomitant losartan or lisinopril
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Forest Laboratories
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John Shea, MS
Role: STUDY_DIRECTOR
Forest Research Institute, a subdisiary of Forest Laboratories, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Forest Investigative Site 058
Athens, Alabama, United States
Forest Investigative Site 101
Birmingham, Alabama, United States
Forest Investigative Site 016
Huntsville, Alabama, United States
Forest Investigative Site 119
Phoenix, Arizona, United States
Forest Investigative Site 078
Tucson, Arizona, United States
Forest Investigative Site 056
Anaheim, California, United States
Forest Investigative Site 097
Bell Gardens, California, United States
Forest Investigative Site 026
Buena Park, California, United States
Forest Investigative Site 147
Buena Park, California, United States
Forest Investigative Site 061
Chino, California, United States
Forest Investigative Site 108
Costa Mesa, California, United States
Forest Investigative Site 054
Encinitas, California, United States
Forest Investigative Site 128
Fresno, California, United States
Forest Investigative Site 127
Huntington Park, California, United States
Forest Investigative Site 030
Long Beach, California, United States
Forest Investigative Site 085
Los Angeles, California, United States
Forest Investigative Site 028
Los Angeles, California, United States
Forest Investigative Site 124
National City, California, United States
Forest Investigative Site 117
Riverside, California, United States
Forest Investigative Site 025
Roseville, California, United States
Forest Investigative Site 017
Sacramento, California, United States
Forest Investigative Site 068
San Diego, California, United States
Forest Investigative Site 112
Santa Ana, California, United States
Forest Investigative Site 063
Temecula, California, United States
Forest Investigative Site 013
Tustin, California, United States
Forest Investigative Site 052
Walnut Creek, California, United States
Forest Investigative Site 074
Milford, Connecticut, United States
Forest Investigative Site 139
Brooksville, Florida, United States
Forest Investigative Site 103
Coral Gables, Florida, United States
Forest Investigative Site 019
Daytona Beach, Florida, United States
Forest Investigative Site 010
DeLand, Florida, United States
Forest Investigative Site 073
Hialeah, Florida, United States
Forest Investigative Site 109
Hialeah, Florida, United States
Forest Investigative Site 036
Hollywood, Florida, United States
Forest Investigative Site 104
Miami, Florida, United States
Forest Investigative Site 121
Miami, Florida, United States
Forest Investigative Site 099
Miami, Florida, United States
Forest Investigative Site 107
Pembroke Pines, Florida, United States
Forest Investigative Site 141
St. Petersburg, Florida, United States
Forest Investigative Site 140
Tampa, Florida, United States
Forest Investigative Site 060
West Palm Beach, Florida, United States
Forest Investigative Site 125
West Palm Beach, Florida, United States
Forest Investigative Site 075
Atlanta, Georgia, United States
Forest Investigative Site 072
Atlanta, Georgia, United States
Forest Investigative Site 042
Augusta, Georgia, United States
Forest Investigative Site 094
Honolulu, Hawaii, United States
Forest Investigative Site 95
Meridian, Idaho, United States
Forest Investigative Site 082
Chicago, Illinois, United States
Forest Investigative Site 096
Wichita, Kansas, United States
Forest Investigative Site 065
Madisonville, Kentucky, United States
Forest Investigative Site 123
Lafayette, Louisiana, United States
Forest Investigative Site 106
Auburn, Maine, United States
Forest Investigative Site 006
Oxon Hill, Maryland, United States
Forest Investigative Site 067
Brockton, Massachusetts, United States
Forest Investigative Site 110
Brockton, Massachusetts, United States
Forest Investigative Site 018
Paw Paw, Michigan, United States
Forest Investigative Site 021
Saint Clair Shores, Michigan, United States
Forest Investigative Site 080
Columbia, Missouri, United States
Forest Investigative Site 146
Elizabeth, New Jersey, United States
Forest Investigative Site 071
Brooklyn, New York, United States
Forest Investigative Site 081
New York, New York, United States
Forest Investigative Site 035
Charlotte, North Carolina, United States
Forest Investigative Site 051
Charlotte, North Carolina, United States
Forest Investigative Site 077
Durham, North Carolina, United States
Forest Investigative Site 100
Lenoir, North Carolina, United States
Forest Investigative Site 041
Morehead City, North Carolina, United States
Forest Investigative Site 050
Salisbury, North Carolina, United States
Forest Investigative Site 091
Centerville, Ohio, United States
Forest Investigative Site 089
Cincinnati, Ohio, United States
Forest Investigative Site 122
Perrysburg, Ohio, United States
Forest Investigative Site 087
Eugene, Oregon, United States
Forest Investigative Site 088
Portland, Oregon, United States
Forest Investigative Site 114
Harleysville, Pennsylvania, United States
Forest Investigative Site 083
Pawtucket, Rhode Island, United States
Forest Investigative Site 098
Columbia, South Carolina, United States
Forest Investigative Site 115
Greer, South Carolina, United States
Forest Investigative Site 105
Simpsonville, 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 116
Houston, Texas, United States
Forest Investigative Site 120
Odessa, Texas, United States
Forest Investigative Site 012
San Antonio, Texas, United States
Forest Investigative Site 048
Sugar Land, Texas, United States
Forest Investigative Site 040
Bountiful, Utah, United States
Forest Investigative Site 062
Salt Lake City, Utah, United States
Forest Investigative Site 093
Salt Lake City, Utah, United States
Forest Investigative Site 130
West Jordan, Utah, United States
Forest Investigative Site 126
Arlington, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEB-MD-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.