Phase III trial of LCZ 696 for Heart Failure closes early - Novartis
Novartis has announced that the Data Monitoring Committee unanimously recommended early closure of the Phase III PARADIGM-HF study of LCZ 696 in patients wth Chronic Heart Failure. Results indicate that patients with Chronic Heart Failure with reduced ejection fraction (HF-REF) who received LCZ 696 lived longer without being hospitalized for Heart Failure than those who received standard care with ACE-inhibitor enalapril.
Based on the compelling efficacy and primary endpoint having been met, the trial will now close early. This follows two previous interim analyses that showed the safety profile of LCZ 696 was acceptable. The results of PARADIGM-HF will be submitted to a major medical conference for presentation and Novartis will now initiate discussions with global health authorities regarding approval for marketing.
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