Heart Failure MedDRA version: 20.0 Level: HLGT Classification code 10019280 Term: Heart failures System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Entresto
Product Name: LCZ696 12.5 mg film-coated granules in capsule (4 x 3.125 mg film-coated granules)
Product Code: LCZ696
Pharmaceutical Form: Film-coated granules
INN or Proposed INN
Sponsors
Novartis Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent - Completed PANORAMA-HF OLE study and safely enrolled Are the trial subjects under 18? yes Number of subjects for this age range: 8 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Permanently discontinued the study treatment during PANORAMA-HF OLE study - Renal vascular hypertension (including renal artery stenosis) - History of angioedema - Having parents or legal guardians who do not give consent or allow the child to give assent, or inability of patient or the parents/legal guardians to follow instructions or comply with follow-up procedures - Any medical condition(s) that may put the patient at risk in the Investigator's opinion or that the Investigator deems unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect additional safety information of sacubitril/valsartan in Japanese patients after long-term treatment of sacubitril/valsartan in CLCZ696B2319E1 study;Secondary Objective: Not applicable;Primary end point(s): Adverse events (AEs);Timepoint(s) of evaluation of this end point: up to 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Japan
Contacts
Public ContactStudy Director
Novartis Pharmaceuticals
Outcome results
None listed