Conditions: Essential Hypertension
Keywords: Hypertension, blood pressure, LCZ696, dual inhibitor, neprilysin, NEP inhibition, vasopeptidase, ARNi, angiotensin receptor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 588
Healthy volunteers: no

Brief summary:
The purpose of this study is to access the efficacy and safety of LCZ696 compared to olmesartan in elderly Asian patients for the treatment of hypertension.

Detailed description:

Arms:
arm 1: Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd. arm 2: Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.

Interventions: intervention 1: Olmesartan intervention 2: Placebo intervention 3: LCZ696
Intervention descriptions: intervention 1: 10 mg, 20 mg, 40 mg capsules intervention 2: Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule intervention 3: 100 mg, 200 mg tablets

Protocol document: