In this multicentre study (24 centres), adults with stage 1 or 2 hypertension not adequately controlled with valsartan monotherapy were randomised to receive double-blind amlodipine/valsartan 5/160 mg SPC or valsartan 160 mg once daily for 8 weeks.
The least-square mean change (standard error) from baseline to endpoint in mean sitting diastolic blood pressure (MSDBP) at trough, the primary efficacy variable, was - 10.3 (0.39) mm Hg with amlodipine/valsartan and - 6.6 (0.40) mm Hg with valsartan (difference: - 3.7 [0.54] mm Hg, p < 0.0001). The corresponding results for mean sitting systolic blood pressure (MSSBP) were - 14.9 (0.61) mm Hg and - 7.0 (0.61) mm Hg, respectively (difference: - 7.9 [0.84] mm Hg, p < 0.0001). A significantly greater proportion of patients achieved overall BP control (MSSBP/MSDBP < 140/90 mm Hg) with combination therapy (61.3 % ) versus monotherapy (39.3 % ; p < 0.0001). Both treatments were well tolerated.
Amlodipine/valsartan 5/160 mg SPC is a safe and effective therapy for lowering BP in predominantly Chinese adults with stage 1 or 2 hypertension not adequately controlled with valsartan 160 mg monotherapy.