A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

Phase 3 Completed 2572 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

Timeline

Start: 2017-08-22
Primary completion: 2019-10-28
Completion: 2019-10-28

Publications

Pieske B, Wachter R, Shah SJ, Baldridge A, Szeczoedy P, Ibram G, Shi V, Zhao Z, Cowie MR; PARALLAX Investigators and Committee members. Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enalapril	Other / unclassified	2.5 mg	Oral
Subject	Enalapril	Other / unclassified	5 mg	Oral
Subject	Enalapril	Other / unclassified	10 mg	Oral
Subject	Valsartan	Small molecule	40 mg	Oral
Subject	Valsartan	Small molecule	80 mg	Oral
Subject	Valsartan	Small molecule	160 mg	Oral
Subject	sacubitril/valsartan	Unknown	50 mg	Oral
Subject	sacubitril/valsartan	Unknown	100 mg	Oral
Subject	sacubitril/valsartan	Unknown	200 mg	Oral

A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

Summary

Timeline

Publications

Drugs

Indications