drugset / Trial / NCT04637555

Open-label Extension Study for CLCZ696G2301 (PARADISE-MI)

NCT04637555 ↗

Phase 3 Withdrawn Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to collect long-term safety and tolerability data of LCZ696 and to provide open-label LCZ696 to eligible participants who completed CLCZ696G2301 study (PARADISE-MI) if LCZ696 is shown to have a positive benefit-risk profile in comparison to ramipril in reducing risk of cardiovascular (CV) mortality and development of heart failure in participants enrolled in the PARADISE-MI study.

Timeline

Start
2021-05-26
Primary completion
2023-06-01
Completion
2023-06-01

Outcome

Outcome not reported

Stopped: “CLCZ696G2301E1 extension study did not start as the core study (CLCZ696G2301) did not meet the primary endpoint.”

Drugs

EvaluationDrugModalityDoseRoute
Subject sacubitril/valsartan Unknown 50 mg —
Subject sacubitril/valsartan Unknown 100 mg —
Subject sacubitril/valsartan Unknown 200 mg —

Indications