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Clinical Trial Summary

Primary Objective: To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable participants after admission for worsening heart failure (WHF) Secondary Objectives: To compare the effects of sotagliflozin to placebo on: - The total occurrences of HHF and urgent visit for HF - The occurrence of CV death - The occurrence of all-cause mortality - The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke - Change in Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score - Change in estimated glomerular filtration rate (eGFR)


Clinical Trial Description

The estimated study duration for a given participants will be approximately 3 to 24 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03521934
Study type Interventional
Source Lexicon Pharmaceuticals
Contact
Status Terminated
Phase Phase 3
Start date June 15, 2018
Completion date June 5, 2020

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