Left ventricular dysfunction following an acute myocardial infarction and/or pulmonary congestion requiring intravenous treatment MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Con
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Participant received study treatment (either in LCZ696 or ramipril treatment arm) in PARADISE-MI. 3. Participant is safe to be enrolled in the extension study and may benefit from the treatment of LCZ696 per investigator's clinical judgement. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 850
Exclusion criteria
Exclusion criteria: 1. Participant with a known history of angioedema 2. History of hypersensitivity to the study drug or drugs of similar chemical classes or known intolerance or contraindications to study drug or drugs of similar chemical classes including ACE inhibitors, ARB or NEP inhibitors 3. Symptomatic hypotension at screening 4. Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at screening 5. Known hepatic impairment (as evidenced by total bilirubin > 3.0 mg/dL or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as esophageal varices 6. Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception 7. Other protocol-defined inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of LCZ696 in participants from PARADISE-MI receiving open-label investigational drug.;Secondary Objective: N/A;Primary end point(s): Adverse events (AEs) leading to permanent study drug discontinuations, temporary study drug interruptions, or study drug dose adjustments; serious adverse events (SAEs), and vital signs;Timepoint(s) of evaluation of this end point: The open-label extension study is expected to last for a duration of 24 months from the time of First Participant First Visit, or until the product becomes available following product launch and subsequent reimbursement for the indication under investigation in the PARADISE-MI study, or the benefit risk-profile of the product is no longer positive, whichever is earlier. (As detailed in the protocol Table 8-1 Assessment Schedule). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Austria, Belgium, Bulgaria, Canada, China, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Korea, Republic of, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactMedisinsk informasjon
Novartis Norge AS
Outcome results
None listed