Conditions: Hypertension
Keywords: hypertension, elderly, central aortic pulse pressure, central pulse pressure, pulse wave velocity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 454
Healthy volunteers: no

Brief summary:
The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).

Detailed description:

Arms:
arm 1: Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study. arm 2: Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.

Interventions: intervention 1: LCZ696 intervention 2: Olmesartan intervention 3: LCZ696 matching placebo intervention 4: Olmesartan matching placebo intervention 5: amlodipine intervention 6: hydrochlorothiazide
Intervention descriptions: intervention 1: 200 mg tablet intervention 2: 20 mg and 40 mg capsules intervention 3: LCZ696 Matching Placebo tablet intervention 4: Olmesartan matching placebo capsule intervention 5: amlodipine 2.5 mg or 5 mg tablets intervention 6: hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets

Protocol document: