A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)
The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.
This was a multicenter, randomized, double-blind, parallel group, active-controlled, study to evaluate the efficacy and safety of sacubitril/valsartan compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction. Specifically, the study evaluated the effect of sacubitril/valsartan compared to the active comparator valsartan in the reduction of the rate of CV death and total HF hospitalizations in patients with HFpEF. The trial consisted of two periods: (1) a single-blind treatment run-in epoch that lasted from 3 to 8 weeks, in which patients received valsartan 80 mg bid, followed by sacubitril/valsartan 100 mg bid and (2) a double-blind randomized treatment epoch (sacubitril/valsartan 200 mg bid or valsartan 160 mg bid). In this study, investigators were responsible for assessing and submitting all events which could potentially fulfill the criteria for the primary, secondary, or other clinical endpoints to a Clinical Endpoint Committee (CEC). Investigator reported events were assessed by the CEC for adjudication.
For angioedema or angioedema-like events, investigators completed an Adjudication Questionnaire for an Angioedema-like Event form. All angioedema reports were forwarded to an Angioedema Adjudication Committee (AAC) by Novartis for assessment.
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
CABA, Buenos Aires 1407, Argentina
CABA, Buenos Aires C1056ABJ, Argentina
Caba, Buenos Aires C1280AEB, Argentina
CABA, Buenos Aires F.D. C1179AAB, Argentina
CABA, C1119ACN, Argentina
Xian, Shanxi 710061, China
Policska, CZE 57201, Czechia
CZE, 11000, Czechia
Muehldorf Am Inn, 84453, Germany
Nyiregyháza, 4400, Hungary
Lower Galilee, Israel 15208, Israel
Tel Giborim, Holon, 58100, Israel
Chiyoda-ku, Tokyo 101-8309, Japan
Itabashi-ku, Tokyo 173-8610, Japan
Shinagawa-ku, Tokyo 142-8666, Japan
Loerenskog, NO 1478, Norway
Warszawa/Anin, 04-761, Poland
N.Novgorod, 603005, Russia
Western Cape, 7130, South Africa
Bundang Gu, Gyeonggi-do 13620, South Korea
Pendik / Istanbul, Turkey 34899, Turkey (Türkiye)
Haydarpasa Istanbul, 34668, Turkey (Türkiye)
Cheshire, CW1 4QJ, United Kingdom
Wiltshire, SN15 2SB, United Kingdom