Statements (60)
Predicate | Object |
---|---|
gptkbp:instance_of |
gptkb:legal_case
|
gptkbp:advocates_for |
informed consent required
|
gptkbp:age |
18 years and older
|
gptkbp:analysis |
intention-to-treat
|
gptkbp:analyzes |
gptkb:Dr._Milton_Packer
|
gptkbp:business_model |
gptkb:battle
|
gptkbp:challenges |
reduced risk of death from cardiovascular causes
reduced risk of hospitalization for heart failure |
gptkbp:clinical_trial |
NC T01950758
improved outcomes in heart failure patients |
gptkbp:collaborations |
multiple research institutions
|
gptkbp:collection |
clinical assessments
laboratory tests electrocardiograms patient-reported outcomes |
gptkbp:completed |
gptkb:2014
|
gptkbp:criteria |
pregnancy
severe renal impairment history of angioedema chronic heart failure NYHA class II-IV concomitant use of certain medications ejection fraction ≤ 40% |
gptkbp:duration |
approximately 27 months
|
gptkbp:events |
up to 5 years
|
gptkbp:exhibited_at |
sacubitril/valsartan is superior to enalapril
|
gptkbp:field_of_study |
cardiology
|
gptkbp:focuses_on |
heart failure
|
https://www.w3.org/2000/01/rdf-schema#label |
PARADIGM-HF study
|
gptkbp:is_compared_to |
sacubitril/valsartan and enalapril
|
gptkbp:is_studied_in |
gptkb:battle
Phase 3 multicenter |
gptkbp:launched |
gptkb:2011
|
gptkbp:location |
multiple countries
|
gptkbp:members |
enalapril group
|
gptkbp:participants |
hospitalization for heart failure
8,442 cardiovascular death |
gptkbp:products |
gptkb:sacubitril/valsartan
|
gptkbp:provides_information_on |
heart failure management guidelines
|
gptkbp:published_by |
gptkb:New_England_Journal_of_Medicine
|
gptkbp:published_year |
gptkb:2014
|
gptkbp:receives_funding_from |
gptkb:Company
|
gptkbp:recorded_by |
gptkb:battle
|
gptkbp:regulatory_compliance |
gptkb:battle
|
gptkbp:research |
published in peer-reviewed journals
interventional study |
gptkbp:result |
gptkb:2014
|
gptkbp:side_effect |
renal impairment
hypotension hyperkalemia |
gptkbp:sponsor |
gptkb:Novartis
|
gptkbp:subject |
PARADIGM-ALTO
PARADIGM-EXTEND PARADIGM-RESEARCH |
gptkbp:target_audience |
patients with heart failure and reduced ejection fraction
|
gptkbp:vision |
gptkb:battle
|
gptkbp:bfsParent |
gptkb:Entresto
|
gptkbp:bfsLayer |
4
|