Conditions: Systolic Hypertension
Keywords: hypertension blood pressure LCZ696 dual-acting neprilysin nep inhibitor vasopeptidase angiotensin receptor angiotensin receptor neprilysin inhibitor (ARNi)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 910
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).

Detailed description:

Arms:
arm 1: Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. arm 2: Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. arm 3: Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. arm 4: Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks. arm 5: Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks. arm 6: Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks. arm 7: Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.

Interventions: intervention 1: LCZ696 intervention 2: Valsartan intervention 3: AHU377 intervention 4: Placebo
Intervention descriptions: intervention 1: LCZ696 was supplied as tablets in blister cards in 100 mg strengths. intervention 2: Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths. intervention 3: AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths. intervention 4: Placebo was supplied as tablets in blister cards.

Protocol document: