Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension
NCT ID: NCT01415505
Last Updated: 2013-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
812 participants
INTERVENTIONAL
2011-08-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Nebivolol and Valsartan free tablet combination
Nebivolol, Valsartan and Hydrochlorothiazide
Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), oral administration
Interventions
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Nebivolol, Valsartan and Hydrochlorothiazide
Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), oral administration
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with stage 1 or stage 2 essential hypertension
* Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant
Exclusion Criteria
* Clinically significant cardiovascular disease or heart failure
* A medical contraindication to discontinuing a current antihypertensive therapy
* History of Type 1 diabetes mellitus
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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David B Bharucha, MD, PhD, FACC
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site 083
Birmingham, Alabama, United States
Forest Investigative Site 004
Foley, Alabama, United States
Forest Investigative Site 038
Gulf Shores, Alabama, United States
Forest Investigative Site 124
Muscle Shoals, Alabama, United States
Forest Investigative Site 023
Chandler, Arizona, United States
Forest Investigative Site 073
Goodyear, Arizona, United States
Forest Investigative Site 100
Green Valley, Arizona, United States
Forest Investigative Site 117
Mesa, Arizona, United States
Forest Investigative Site 065
Mesa, Arizona, United States
Forest Investigative Site 102
Phoenix, Arizona, United States
Forest Investigative Site 103
Tempe, Arizona, United States
Forest Investigative Site 068
Tempe, Arizona, United States
Forest Investigative Site 066
Jonesboro, Arkansas, United States
Forest Investigative Site 118
Jonesboro, Arkansas, United States
Forest Investigative Site 135
Carmichael, California, United States
Forest Investigative Site 064
Encinitas, California, United States
Forest Investigative Site 046
Encino, California, United States
Forest Investigative Site 098
Glendale, California, United States
Forest Investigative Site 129
Huntington Park, California, United States
Forest Investigative Site 136
Lancaster, California, United States
Forest Investigative Site 096
Long Beach, California, United States
Forest Investigative Site 015
Los Angeles, California, United States
Forest Investigative Site 025
Los Angeles, California, United States
Forest Investigative Site 101
Mission Hills, California, United States
Forest Investigative Site 089
Palm Springs, California, United States
Forest Investigative Site 116
Pismo Beach, California, United States
Forest Investigative Site 138
Sacramento, California, United States
Forest Investigative Site 132
San Diego, California, United States
Forest Investigative Site 061
San Marino, California, United States
Forest Investigative Site 095
San Ramon, California, United States
Forest Investigative Site 087
Santa Ana, California, United States
Forest Investigative Site 134
Santa Barbara, California, United States
Forest Investigative Site 062
Tustin, California, United States
Forest Investigative Site 130
Tustin, California, United States
Forest Investigative Site 092
West Hills, California, United States
Forest Investigative Site 028
Westlake Village, California, United States
Forest Investigative Site 006
Northglenn, Colorado, United States
Forest Investigative Site 030
Cromwell, Connecticut, United States
Forest Investigative Site 018
Waterbury, Connecticut, United States
Forest Investigative Site 106
Boca Raton, Florida, United States
Forest Investigative Site 044
Brooksville, Florida, United States
Forest Investigative Site 049
Coral Gables, Florida, United States
Forest Investigative Site 069
Cutler Bay, Florida, United States
Forest Investigative Site 059
Daytona Beach, Florida, United States
Forest Investigative Site 048
Fort Lauderdale, Florida, United States
Forest Investigative Site 001
Fort Lauderdale, Florida, United States
Forest Investigative Site 002
Hialeah, Florida, United States
Forest Investigative Site 022
Miami, Florida, United States
Forest Investigative Site 032
Miami, Florida, United States
Forest Investigative Site 005
New Port Richey, Florida, United States
Forest Investigative Site 021
North Miami Beach, Florida, United States
Forest Investigative Site 111
Ocala, Florida, United States
Forest Investigative Site 056
Pembroke Pines, Florida, United States
Forest Investigative Site 127
Pembroke Pines, Florida, United States
Forest Investigative Site 054
Pembroke Pines, Florida, United States
Forest Investigative Site 133
Pembroke Pines, Florida, United States
Forest Investigative Site 085
Plant City, Florida, United States
Forest Investigative Site 033
Tampa, Florida, United States
Forest Investigative Site 008
Winter Haven, Florida, United States
Forest Investigative Site 019
Atlanta, Georgia, United States
Forest Investigative Site 077
Roswell, Georgia, United States
Forest Investigative Site 126
Arlington Heights, Illinois, United States
Forest Investigative Site 084
Chicago, Illinois, United States
Forest Investigative Site 088
Evansville, Indiana, United States
Forest Investigative Site 108
Newton, Kansas, United States
Forest Investigative Site 050
Lexington, Kentucky, United States
Forest Investigative Site 003
Madisonville, Kentucky, United States
Forest Investigative Site 141
Metairie, Louisiana, United States
Forest Investigative Site 057
Auburn, Maine, United States
Forest Investigative Site 041
Baltimore, Maryland, United States
Forest Investigative Site 014
Baltimore, Maryland, United States
Forest Investigative Site 080
Elkridge, Maryland, United States
Forest Investigative Site 017
Haverhill, Massachusetts, United States
Forest Investigative Site 143
Kalamazoo, Michigan, United States
Forest Investigative Site 071
Troy, Michigan, United States
Forest Investigative Site 086
Jackson, Mississippi, United States
Forest Investigative Site 099
Omaha, Nebraska, United States
Forest Investigative Site 120
Las Vegas, Nevada, United States
Forest Investigative Site 119
Las Vegas, Nevada, United States
Forest Investigative Site 121
Las Vegas, Nevada, United States
Forest Investigative Site 137
Berkeley Heights, New Jersey, United States
Forest Investigative Site 047
Binghamton, New York, United States
Forest Investigative Site 072
Rosedale, New York, United States
Forest Investigative Site 128
Saratoga Springs, New York, United States
Forest Investigative Site 042
Charlotte, North Carolina, United States
Forest Investigative Site 139
Greensboro, North Carolina, United States
Forest Investigative Site 007
Hickory, North Carolina, United States
Forest Investigative Site 114
Lenoir, North Carolina, United States
Forest Investigative Site 081
Salisbury, North Carolina, United States
Forest Investigative Site 013
Shelby, North Carolina, United States
Forest Investigative Site 011
Wilmington, North Carolina, United States
Forest Investigative Site 036
Winston-Salem, North Carolina, United States
Forest Investigative Site 009
Cincinnati, Ohio, United States
Forest Investigative Site 125
Kettering, Ohio, United States
Forest Investigative Site 094
Marion, Ohio, United States
Forest Investigative Site 093
Mount Gilead, Ohio, United States
Forest Investigative Site 112
Oklahoma City, Oklahoma, United States
Forest Investigative Site 104
Eugene, Oregon, United States
Forest Investigative Site 058
Beaver, Pennsylvania, United States
Forest Investigative Site 131
Penndel, Pennsylvania, United States
Forest Investigative Site 105
Philadelphia, Pennsylvania, United States
Forest Investigative Site 039
Upper Saint Clair, Pennsylvania, United States
Forest Investigative Site 012
Charleston, South Carolina, United States
Forest Investigative Site 040
Columbia, South Carolina, United States
Forest Investigative Site 060
Greer, South Carolina, United States
Forest Investigative Site 035
Mt. Pleasant, South Carolina, United States
Forest Investigative Site 082
Mt. Pleasant, South Carolina, United States
Forest Investigative Site 142
Simpsonville, South Carolina, United States
Forest Investigative Site 045
Summerville, South Carolina, United States
Forest Investigative Site 113
Bristol, Tennessee, United States
Forest Investigative Site 034
Fayetteville, Tennessee, United States
Forest Investigative Site 070
Franklin, Tennessee, United States
Forest Investigative Site 016
Arlington, Texas, United States
Forest Investigative Site 063
Carrollton, Texas, United States
Forest Investigative Site 123
Dallas, Texas, United States
Forest Investigative Site 079
Fort Worth, Texas, United States
Forest Investigative Site 052
Houston, Texas, United States
Forest Investigative Site 024
Houston, Texas, United States
Forest Investigative Site 026
Houston, Texas, United States
Forest Investigative Site 027
Houston, Texas, United States
Forest Investigative Site 140
Plano, Texas, United States
Forest Investigative Site 091
San Angelo, Texas, United States
Forest Investigative Site 055
San Antonio, Texas, United States
Forest Investigative Site 115
San Antonio, Texas, United States
Forest Investigative Site 078
Sugar Land, Texas, United States
Forest Investigative Site 090
Salt Lake City, Utah, United States
Forest Investigative Site 053
Salt Lake City, Utah, United States
Forest Investigative Site 051
St. George, Utah, United States
Forest Investigative Site 110
Alexandria, Virginia, United States
Forest Investigative Site 074
Burke, Virginia, United States
Forest Investigative Site 067
Manassas, Virginia, United States
Forest Investigative Site 037
Norfolk, Virginia, United States
Forest Investigative Site 122
Suffolk, Virginia, United States
Forest Investigative Site 010
Virginia Beach, Virginia, United States
Forest Investigative Site 107
Tacoma, Washington, United States
Countries
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References
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Neutel JM, Giles TD, Punzi H, Weiss RJ, Li H, Finck A. Long-term safety of nebivolol and valsartan combination therapy in patients with hypertension: an open-label, single-arm, multicenter study. J Am Soc Hypertens. 2014 Dec;8(12):915-20. doi: 10.1016/j.jash.2014.09.017. Epub 2014 Sep 28.
Other Identifiers
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NAC-MD-02
Identifier Type: -
Identifier Source: org_study_id
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