4,161
Participants
Start Date
January 31, 2012
Primary Completion Date
March 31, 2013
Study Completion Date
May 31, 2013
Nebivolol and Valsartan 1
Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg, oral administration, then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration
Nebivolol and Valsartan 2
Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 320 mg, oral administration
Nebivolol and Valsartan 3
Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 20 mg and Valsartan 320 mg, oral administration
Nebivolol 1
Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
Nebivolol 2
Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
Valsartan 1
Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
Valsartan 2
Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
Placebo
Dose matched placebo, oral administration
Forest Investigative Site 1796, Brooklyn
Forest Investigative Site 1021, Glen Falls
Forest Investigative Site 1151, Buffalo
Forest Investigative Site 1115, Rochester
Forest Investigative Site 1218, Carnegie
Forest Investigative Site 1137, Pittsburgh
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Forest Investigative Site 1760, Charleston
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Forest Investigative Site 1127, Mt. Pleasant
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Forest Investigative Site 1327, Greer
Forest Investigative Site 1152, Pelzer
Forest Investigative Site 1114, Simpsonville
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Forest Investigative Site 1236, Lilburn
Forest Investigative Site 1389, Marietta
Forest Investigative Site 1002, Marietta
Forest Investigative Site 1353, Snellville
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Forest Investigative Site 1739, South Miami
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Forest Investigative Site 1297, Miami Springs
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Forest Investigative Site 1378, Doral
Forest Investigative Site 1223, Miami
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Forest Investigative Site 1282, Miami
Forest Investigative Site 1221, Cutler Bay
Forest Investigative Site 1068, Fort Lauderdale
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Forest Investigative Site 1330, Fort Lauderdale
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Forest Investigative Site 1266, Deerfield Beach
Forest Investigative Site 1077, Jupiter
Forest Investigative Site 1042, Brandon
Forest Investigative Site 1023, Plant City
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Forest Investigative Site 1730, St. Petersburg
Forest Investigative Site 1764, Clearwater
Forest Investigative Site 1368, Pinellas Park
Forest Investigative Site 1120, Winter Haven
Forest Investigative Site 1007, Bradenton
Forest Investigative Site 1702, Brooksville
Forest Investigative Site 1708, New Port Richey
Forest Investigative Site 1284, Oldsmar
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Forest Investigative Site 1763, Kingsport
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Forest Investigative Site 1074, Collierville
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Forest Investigative Site 1768, Traverse City
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Forest Investigative Site 1185, Dakota Dunes
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Forest Investigative Site 1403, Hazel Crest
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Forest Investigative Site 1126, Morton
Forest Investigative Site 1283, O'Fallon
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Lead Sponsor
Forest Laboratories
INDUSTRY