drugset / Trial / NCT01692301

Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension

NCT01692301 ↗

Phase 2 Completed 454 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2012-12
Primary completion
2015-04
Completion
2015-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); LCZ696 (Sacubitril/Valsartan) vs Olmesartan; p = 0.010; Mean Difference (Net) -3.66 (95% CI -6.45 to -0.87); ANCOVA NCT01692301 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject LCZ696 Unknown 400 mg —
Subject Olmesartan Other / unclassified 40 mg —
Background Amlodipine Other / unclassified 2.5 mg —
Background Amlodipine Other / unclassified 5 mg —
Background Hydrochlorothiazide Unknown 6.25 mg —
Background Hydrochlorothiazide Unknown 12.5 mg —
Background Hydrochlorothiazide Unknown 25 mg —

Indications