Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Long-term Safety of LCZ696 in Post-MI Patients (PARADISE-MI Extension)
NCT04637555Phase 3
Key facts
- Status
- Withdrawn
- Start
- May 2021
- Primary completion
- Jun 2023
- Sponsor
- Novartis
- Modality
- Small Molecules
- Conditions
- myocardial infarction (MI)
01
Overview
Phase 3, open-label, single-arm trial of sacubitril + valsartan in myocardial infarction (MI), sponsored by Novartis. Primary endpoints: Number of participants with AE(s) leading to permanent study drug discontinuation, temporary study drug interruption, or study drug dose adjustment up to 24 months, Number of participants with Serious Adverse Events (SAEs) up to 24 months and 1 more. Planned start May 2021; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
LCZ696 Arm
All patients receive open-label LCZ696
03
Endpoints
Primary
Number of participants with AE(s) leading to permanent study drug discontinuation, temporary study drug interruption, or study drug dose adjustment
Number of participants with Serious Adverse Events (SAEs)
Vital signs (Blood Pressure and pulse)
Beyond the preview
Go deeper on NCT04637555.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04637555.