To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4,161
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
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
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
Change in Sitting Diastolic Blood Pressure (DBP)
Time frame: from basline to Week 8
Change in Sitting Systolic Blood Pressure (SBP)
Time frame: from baseline to Week 8
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Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
Dose matched placebo, oral administration
Forest Investigative Site 1750
Birmingham, Alabama, United States
Forest Investigative Site 1038
Birmingham, Alabama, United States
Forest Investigative Site 1308
Birmingham, Alabama, United States
Forest Investigative Site 1192
Birmingham, Alabama, United States
Forest Investigative Site 1005
Birmingham, Alabama, United States
Forest Investigative Site 1047
Foley, Alabama, United States
Forest Investigative Site 1717
Gulf Shores, Alabama, United States
Forest Investigative Site 1056
Mobile, Alabama, United States
Forest Investigative Site 1719
Muscle Shoals, Alabama, United States
Forest Investigative Site 1145
Glendale, Arizona, United States
...and 403 more locations