drugset / Trial / NCT00549770

Efficacy and Safety of LCZ696A in Patients With Essential Hypertension

NCT00549770 ↗

Phase 2 Completed 1334 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

Timeline

Start
2007-09
Primary completion
2008-07
Completion
2008-07

Outcome

Met primary endpoint

paper The average reduction in mean sitting diastolic blood pressure across the doses of LCZ696 versus the appropriate comparator dose of valsartan showed significantly greater reductions with LCZ696 (mean reduction: -2.17 mm Hg, 95% CI -3.28 to -1.06; p<0.0001). PMID 20236700 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject LCZ696 Unknown 100 mg Oral
Subject LCZ696 Unknown 200 mg Oral
Subject LCZ696 Unknown 400 mg Oral
Subject Sacubitril Small molecule 200 mg Oral
Comparator Valsartan Unknown 80 mg Oral
Comparator Valsartan Unknown 160 mg Oral
Comparator Valsartan Unknown 320 mg Oral

Indications