Trials / Withdrawn
WithdrawnNCT04637555
Open-label Extension Study for CLCZ696G2301 (PARADISE-MI)
A Multicenter Study to Evaluate the Long-term Safety and Tolerability of Open-label LCZ696 in Patients With Acute Myocardial Infarction Who Previously Participated in CLCZ696G2301 (PARADISE-MI)
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sacubitril/valsartan | LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively |
Timeline
- Start date
- 2021-05-26
- Primary completion
- 2023-06-01
- Completion
- 2023-06-01
- First posted
- 2020-11-19
- Last updated
- 2021-11-26
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04637555. Inclusion in this directory is not an endorsement.