Conditions: Hypertension
Keywords: LCZ696, Hypertension, Aortic stiffness, Central blood pressure, Cardiovascular MRI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 115
Healthy volunteers: no

Brief summary:
This was the first evaluation of the effects of LCZ696 on local and regional measures of aortic stiffness in subjects with mild to moderate hypertension and widened pulse pressure. The results of this exploratory study will help to understand the mechanism of action of LCZ696 and used to inform the design of future clinical studies with LCZ696 in subjects with cardiovascular diseases.

Detailed description:

Arms:
arm 1: Single drug treatment period: Patients received LCZ696 200mg once daily (q.d.) + placebo to 20 mg olmesartan q.d for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (400 mg qd LCZ696 + placebo to 40 mg qd olmesartan) for 10 weeks.

Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure. arm 2: Single drug treatment period: Patients received 20 mg olmesartan q.d + placebo to LCZ696 200mg once daily (q.d.) for 2 weeks. After 2 weeks, patients were dosed at the maintenance dose level (40 mg olmesartan q.d + placebo to 400 mg qd LCZ696) for 10 weeks.

Add-on Period: After 12 weeks on single-drug treatment, patients continued in the study on the blinded maintenance dose and if required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to the treatment regimen and titrated according to the investigator's discretion to achieve target blood pressure.

Interventions: intervention 1: sacubitril/valsartan (LCZ696) intervention 2: olmesartan intervention 3: placebo to sacubitril/valsartan (LCZ696) intervention 4: placebo to olmesartan intervention 5: Amlodipine (Optional)
Intervention descriptions: intervention 1: 200 mg tablets intervention 2: None intervention 3: placebo intervention 4: placebo intervention 5: If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen

Protocol document: