Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT01415505
- Lead Sponsor
- Forest Laboratories
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 812
- Male or female outpatients of age 18 years or above
- 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
- Secondary hypertension or severe hypertension
- Clinically significant cardiovascular disease or heart failure
- A medical contraindication to discontinuing a current antihypertensive therapy
- History of Type 1 diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Nebivolol, Valsartan and Hydrochlorothiazide Nebivolol and Valsartan free tablet combination
- Primary Outcome Measures
Name Time Method Adverse Event Recording From Baseline to Week 53 (Visit 16)
- Secondary Outcome Measures
Name Time Method Systolic Blood Pressure (SBP) From Baseline to Week 52 (Visit 15) Diastolic Blood Pressure (DBP). From Baseline to Week 52 (Visit 15)
Trial Locations
- Locations (135)
Forest Investigative Site 124
🇺🇸Muscle Shoals, Alabama, United States
Forest Investigative Site 135
🇺🇸Carmichael, California, United States
Forest Investigative Site 025
🇺🇸Los Angeles, California, United States
Forest Investigative Site 087
🇺🇸Santa Ana, California, United States
Forest Investigative Site 126
🇺🇸Arlington Heights, Illinois, United States
Forest Investigative Site 105
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 040
🇺🇸Columbia, South Carolina, United States
Forest Investigative Site 016
🇺🇸Arlington, Texas, United States
Forest Investigative Site 123
🇺🇸Dallas, Texas, United States
Forest Investigative Site 010
🇺🇸Virginia Beach, Virginia, 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 136
🇺🇸Lancaster, California, United States
Forest Investigative Site 015
🇺🇸Los Angeles, California, United States
Forest Investigative Site 006
🇺🇸Northglenn, Colorado, United States
Forest Investigative Site 108
🇺🇸Newton, Kansas, United States
Forest Investigative Site 102
🇺🇸Phoenix, Arizona, United States
Forest Investigative Site 132
🇺🇸San Diego, California, 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 009
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 112
🇺🇸Oklahoma City, Oklahoma, United States
Forest Investigative Site 055
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 115
🇺🇸San Antonio, 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 022
🇺🇸Miami, Florida, United States
Forest Investigative Site 023
🇺🇸Chandler, Arizona, United States
Forest Investigative Site 018
🇺🇸Waterbury, Connecticut, United States
Forest Investigative Site 021
🇺🇸North Miami Beach, Florida, United States
Forest Investigative Site 085
🇺🇸Plant City, Florida, United States
Forest Investigative Site 001
🇺🇸Fort Lauderdale, Florida, United States
Forest Investigative Site 014
🇺🇸Baltimore, Maryland, United States
Forest Investigative Site 073
🇺🇸Goodyear, Arizona, United States
Forest Investigative Site 048
🇺🇸Fort Lauderdale, Florida, United States
Forest Investigative Site 056
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative Site 059
🇺🇸Daytona Beach, Florida, United States
Forest Investigative Site 057
🇺🇸Auburn, Maine, United States
Forest Investigative Site 117
🇺🇸Mesa, Arizona, United States
Forest Investigative Site 068
🇺🇸Tempe, Arizona, United States
Forest Investigative Site 142
🇺🇸Simpsonville, South Carolina, United States
Forest Investigative Site 100
🇺🇸Green Valley, Arizona, United States
Forest Investigative Site 065
🇺🇸Mesa, Arizona, United States
Forest Investigative Site 066
🇺🇸Jonesboro, Arkansas, United States
Forest Investigative Site 118
🇺🇸Jonesboro, Arkansas, United States
Forest Investigative Site 030
🇺🇸Cromwell, Connecticut, United States
Forest Investigative Site 002
🇺🇸Hialeah, Florida, United States
Forest Investigative Site 111
🇺🇸Ocala, Florida, United States
Forest Investigative Site 044
🇺🇸Brooksville, Florida, United States
Forest Investigative Site 069
🇺🇸Cutler Bay, Florida, United States
Forest Investigative Site 127
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative Site 017
🇺🇸Haverhill, Massachusetts, United States
Forest Investigative Site 133
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative Site 008
🇺🇸Winter Haven, Florida, United States
Forest Investigative Site 041
🇺🇸Baltimore, Maryland, United States
Forest Investigative Site 070
🇺🇸Franklin, Tennessee, United States
Forest Investigative Site 035
🇺🇸Mt. Pleasant, South Carolina, United States
Forest Investigative Site 086
🇺🇸Jackson, Mississippi, United States
Forest Investigative Site 071
🇺🇸Troy, Michigan, United States
Forest Investigative Site 080
🇺🇸Elkridge, Maryland, United States
Forest Investigative Site 143
🇺🇸Kalamazoo, Michigan, United States
Forest Investigative Site 137
🇺🇸Berkeley Heights, New Jersey, United States
Forest Investigative Site 104
🇺🇸Eugene, Oregon, United States
Forest Investigative Site 060
🇺🇸Greer, 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 051
🇺🇸St. George, Utah, United States
Forest Investigative Site 033
🇺🇸Tampa, Florida, United States
Forest Investigative Site 099
🇺🇸Omaha, Nebraska, United States
Forest Investigative Site 050
🇺🇸Lexington, Kentucky, United States
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 103
🇺🇸Tempe, Arizona, United States
Forest Investigative Site 064
🇺🇸Encinitas, California, United States
Forest Investigative Site 046
🇺🇸Encino, California, United States
Forest Investigative Site 129
🇺🇸Huntington Park, California, United States
Forest Investigative Site 098
🇺🇸Glendale, 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 061
🇺🇸San Marino, California, United States
Forest Investigative Site 095
🇺🇸San Ramon, California, United States
Forest Investigative Site 134
🇺🇸Santa Barbara, California, United States
Forest Investigative Site 092
🇺🇸West Hills, California, United States
Forest Investigative Site 028
🇺🇸Westlake Village, California, United States
Forest Investigative Site 130
🇺🇸Tustin, California, United States
Forest Investigative Site 062
🇺🇸Tustin, California, United States
Forest Investigative Site 106
🇺🇸Boca Raton, Florida, United States
Forest Investigative Site 049
🇺🇸Coral Gables, Florida, United States
Forest Investigative Site 032
🇺🇸Miami, Florida, United States
Forest Investigative Site 005
🇺🇸New Port Richey, Florida, United States
Forest Investigative Site 054
🇺🇸Pembroke Pines, Florida, United States
Forest Investigative Site 084
🇺🇸Chicago, Illinois, United States
Forest Investigative Site 019
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 077
🇺🇸Roswell, Georgia, United States
Forest Investigative Site 088
🇺🇸Evansville, Indiana, United States
Forest Investigative Site 141
🇺🇸Metairie, Louisiana, United States
Forest Investigative Site 003
🇺🇸Madisonville, Kentucky, United States
Forest Investigative Site 047
🇺🇸Binghamton, New York, United States
Forest Investigative Site 042
🇺🇸Charlotte, North Carolina, United States
Forest Investigative Site 072
🇺🇸Rosedale, New York, United States
Forest Investigative Site 128
🇺🇸Saratoga Springs, New York, United States
Forest Investigative Site 007
🇺🇸Hickory, North Carolina, United States
Forest Investigative Site 139
🇺🇸Greensboro, 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 094
🇺🇸Marion, Ohio, United States
Forest Investigative Site 125
🇺🇸Kettering, Ohio, United States
Forest Investigative Site 093
🇺🇸Mount Gilead, Ohio, United States
Forest Investigative Site 058
🇺🇸Beaver, Pennsylvania, United States
Forest Investigative Site 131
🇺🇸Penndel, Pennsylvania, United States
Forest Investigative Site 039
🇺🇸Upper St. Clair, Pennsylvania, United States
Forest Investigative Site 082
🇺🇸Mt. Pleasant, South Carolina, United States
Forest Investigative Site 063
🇺🇸Carrollton, Texas, United States
Forest Investigative Site 091
🇺🇸San Angelo, Texas, United States
Forest Investigative Site 140
🇺🇸Plano, Texas, United States
Forest Investigative Site 078
🇺🇸Sugar Land, Texas, United States
Forest Investigative Site 074
🇺🇸Burke, Virginia, United States
Forest Investigative Site 110
🇺🇸Alexandria, 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 107
🇺🇸Tacoma, Washington, United States
Forest Investigative Site 079
🇺🇸Fort Worth, Texas, United States
Forest Investigative Site 096
🇺🇸Long Beach, California, United States
Forest Investigative Site 138
🇺🇸Sacramento, California, United States
Forest Investigative Site 036
🇺🇸Winston-Salem, North Carolina, United States
Forest Investigative Site 012
🇺🇸Charleston, South Carolina, United States