At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 794 enrolled
Drug / intervention
LCZ696 (sacubitril/valsartan)drug
Likely dose
LCZ696 (sacubitril/valsartan) 26 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 52 Week, Open Label Evaluation of the Effects of Sacubitril/Valsartan (LCZ696) Therapy on Biomarkers, Myocardial Remodeling and Patient-reported Outcomes in Heart Failure With Reduced Left Ventricular Ejection Fraction.
In Brief
A Phase 4 clinical trial evaluating LCZ696 (sacubitril/valsartan) for Heart Failure. Completed, enrolled 794 participants across 77 sites.
Detailed Summary
This study was to determine early and more chronic changes in concentrations of biomarkers related to mechanisms of action (MOA) and effects of sacubitril/valsartan therapy over a period of 12 months, and correlated these biomarker changes with cardiac remodeling parameters, patient-reported outcomes and cardiovascular outcomes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartOct 2016
Primary CompletionOct 2018
TodayJul 2026
First PostedSep 2, 2016
Enrollment StartOct 25, 2016
Primary CompletionOct 22, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.8 years ago
Interventions
LCZ696 (sacubitril/valsartan)drug
LCZ696 (sacubitril/valsartan) was supplied as unscored, ovaloid, film-coated oral tablets in the strengths of 24/26 mg, 49/51 mg, 97/103 mg to be taken twice daily (bid)