drugset / Trial / NCT00549770
Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
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 ↗
Publications
- Andersen MB, Simonsen U, Wehland M, Pietsch J, Grimm D. LCZ696 (Valsartan/Sacubitril)--A Possible New Treatment for Hypertension and Heart Failure. Basic Clin Pharmacol Toxicol. 2016 Jan;118(1):14-22. doi: 10.1111/bcpt.12453. Epub 2015 Sep 4.
- Ruilope LM, Dukat A, Bohm M, Lacourciere Y, Gong J, Lefkowitz MP. Blood-pressure reduction with LCZ696, a novel dual-acting inhibitor of the angiotensin II receptor and neprilysin: a randomised, double-blind, placebo-controlled, active comparator study. Lancet. 2010 Apr 10;375(9722):1255-66. doi: 10.1016/S0140-6736(09)61966-8. Epub 2010 Mar 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |