OBJECTIVE: To demonstrate additional BP-lowering effects of amlodipine/valsartan combination in patients whose BP was not adequately controlled on valsartan alone. METHODS: This was a multi-centre, randomised, double-blind, active-controlled study in patients with essential hypertension. After a washout period followed by a single-blind valsartan 160 mg run-in period, patients with mean sitting diastolic blood pressure (DBP) >or= 90 mmHg and < 110 mmHg were randomised to receive amlodipine/valsartan (10/160 mg or 5/160 mg o.d.) or valsartan (160 mg o.d.) for 8 weeks. TRIAL REGISTRATION: NCT00170963 MAIN OUTCOME MEASURES: Primary efficacy variable was change from baseline in mean DBP at study end. Secondary efficacy variables included change from baseline in mean sitting systolic blood pressure (SBP), responder rate (mean DBP < 90 mmHg or >or= 10 mmHg reduction from baseline), and DBP control rate (mean DBP < 90 mmHg). Safety was also assessed. RESULTS: Of 1136 patients enrolled in single-blind phase, 947 (mean age: 54.6 years) were randomised. Statistically significantly greater reductions in mean SBP/DBP were observed in both amlodipine/valsartan combinations (10/160 mg: 14.3/11.5 mmHg, 5/160 mg: 12.2/9.6 mmHg; both p < 0.0001) compared to valsartan 160 mg (8.3/6.7 mmHg). The 10/160 mg combination (p < 0.05) showed statistically significantly greater reductions in mean SBP/DBP compared to 5/160 mg (p < 0.001). Responder rates were higher in both combination therapy groups (10/160 mg: 81% [p < 0.0001]; 5/160 mg: 68% [p = 0.0018], respectively) compared to monotherapy (57%). Peripheral oedema was the most frequent adverse event, reported in amlodipine/valsartan 10/160 mg (9.1%), 5/160 mg (0.9%), and valsartan 160 mg (1.3%). CONCLUSIONS: The combination of amlodipine/valsartan in this 8-week double-blind study provided additional BP control and was well-tolerated in patients inadequately controlled with valsartan monotherapy.
RCT Entities:
OBJECTIVE: To demonstrate additional BP-lowering effects of amlodipine/valsartan combination in patients whose BP was not adequately controlled on valsartan alone. METHODS: This was a multi-centre, randomised, double-blind, active-controlled study in patients with essential hypertension. After a washout period followed by a single-blind valsartan 160 mg run-in period, patients with mean sitting diastolic blood pressure (DBP) >or= 90 mmHg and < 110 mmHg were randomised to receive amlodipine/valsartan (10/160 mg or 5/160 mg o.d.) or valsartan (160 mg o.d.) for 8 weeks. TRIAL REGISTRATION: NCT00170963 MAIN OUTCOME MEASURES: Primary efficacy variable was change from baseline in mean DBP at study end. Secondary efficacy variables included change from baseline in mean sitting systolic blood pressure (SBP), responder rate (mean DBP < 90 mmHg or >or= 10 mmHg reduction from baseline), and DBP control rate (mean DBP < 90 mmHg). Safety was also assessed. RESULTS: Of 1136 patients enrolled in single-blind phase, 947 (mean age: 54.6 years) were randomised. Statistically significantly greater reductions in mean SBP/DBP were observed in both amlodipine/valsartan combinations (10/160 mg: 14.3/11.5 mmHg, 5/160 mg: 12.2/9.6 mmHg; both p < 0.0001) compared to valsartan 160 mg (8.3/6.7 mmHg). The 10/160 mg combination (p < 0.05) showed statistically significantly greater reductions in mean SBP/DBP compared to 5/160 mg (p < 0.001). Responder rates were higher in both combination therapy groups (10/160 mg: 81% [p < 0.0001]; 5/160 mg: 68% [p = 0.0018], respectively) compared to monotherapy (57%). Peripheral oedema was the most frequent adverse event, reported in amlodipine/valsartan 10/160 mg (9.1%), 5/160 mg (0.9%), and valsartan 160 mg (1.3%). CONCLUSIONS: The combination of amlodipine/valsartan in this 8-week double-blind study provided additional BP control and was well-tolerated in patients inadequately controlled with valsartan monotherapy.