drugset / Trial / NCT04637555
Open-label Extension Study for CLCZ696G2301 (PARADISE-MI)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sacubitril/valsartan | Unknown | 50 mg | — |
| Subject | sacubitril/valsartan | Unknown | 100 mg | — |
| Subject | sacubitril/valsartan | Unknown | 200 mg | — |