Forest Laboratories announced positive top-line results from an 8-week pivotal Phase 3 clinical trial evaluating the efficacy and safety of investigational fixed dose combination (FDC) of nebivolol, a beta-blocker and valsartan, an angiotensin II receptor blocker (ARB) for the treatment of hypertension.
This pivotal 8-week randomized, double-blind, placebo-controlled clinical trial in 4,161 hypertension patients studied nebivolol 5mg, 10mg, 20mg, and 40mg and valsartan 80mg, 160mg, and 320mg alone and in fixed dose combinations. There was a 1-week screening period, followed by 6 weeks of placebo wash-out, an 8-week double-blind treatment period, and a 1-week down-titration period. During the double-blind treatment period, patients were initially randomized to one of eight treatment groups: FDC nebivolol/valsartan 5/80mg, 5/160mg, or 10/160mg; nebivolol 5mg or 20mg; valsartan 80mg or 160mg or placebo. After four weeks, all dosages were doubled.
The primary endpoint was change from baseline in mean sitting trough DBP at 8 weeks for FDC dose 20/320mg vs. nebivolol 40mg (the highest approved nebivolol dose) and vs. valsartan 320mg (the highest approved valsartan dose), and FDC doses 10/320mg and 10/160mg vs. corresponding monotherapies.
The combination of nebivolol and valsartan demonstrated statistically significant reductions in diastolic blood pressure (DBP) vs. both nebivolol alone and valsartan alone at 8 weeks, which was the primary endpoint. Across the studied doses, the incremental reduction in DBP for the combination vs. nebivolol was -1.2 to -2.4 mmHg; (P value 0.03 to <0.0001) and vs. valsartan was -3.7 to -4.4 mmHg (P value <0.0001).
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