Entresto 97 mg/103 mg film-coated tablets

DRUG4 trials

Sponsors

Laboratorios Normon S.A., Ziekenhuis Oost Limburg, Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy, Slaskie Centrum Chorob Serca W Zabrzu

Conditions

Healthy volunteersHeart failure with preserved ejection fraction Secundary mitral valve regurgitationHeart failure – post-anthracycline cardiomyopathyarrhythmogenic in the old space of cardiomyopathy

Phase 1

Randomised bioequivalence clinical trial of sacubitril/valsartan 97 mg/103 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions in crossover replicated design.

CompletedCTIS2022-503083-32-00

Laboratorios Normon S.A.Healthy volunteers

Start: 2023-03-08End: 2023-04-26Target: 36Updated: 2023-03-07

Phase 3

Sacubitril/valsartan in the prevention of disease progression in patients with an ancient arrhythmogenic service - ARNI-ARVC multicentre randomized trial

RecruitingCTIS2024-517412-29-00

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczyarrhythmogenic in the old space of cardiomyopathy

Start: 2023-07-10Target: 120Updated: 2025-05-09

Sacubitril/Valsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent. Randomized, multicenter, double-blind, placebo-controlled study.

RecruitingCTIS2024-517804-12-00

Slaskie Centrum Chorob Serca W ZabrzuHeart failure – post-anthracycline cardiomyopathy

Start: 2024-04-17Target: 600Updated: 2025-10-26

Phase 4

Sacubitril-Valsartan in Heart Failure with Preserved Ejection Fraction and Secondary Mitral Valve Regurgitation (PRAISE-MR)

Active, not recruitingCTIS2023-506634-70-00

Ziekenhuis Oost LimburgHeart failure with preserved ejection fraction Secundary mitral valve regurgitation

Start: 2024-02-29Target: 110Updated: 2023-10-11