drugset / Trial / NCT02690974

Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejection Fraction (HFrEF) Treated in Real Life Setting

NCT02690974

Phase 4 Completed 302 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelSupportive care

Summary

The primary purpose of the study was to describe the tolerability of treatment with the optimal dose of LCZ696 (97 mg sacubitril / 103 mg valsartan bid), over six (6) months, in patients with heart failure with reduced ejection fraction (HFrEF) in Canada. The study was also to describe the overall tolerability, effectiveness and safety of LCZ696 for the management of HFrEF over 12 months of treatment, as well as describe the patterns of LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.

Timeline

Start
2016-03-08
Primary completion
2017-06-07
Completion
2017-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Sacubitril Small molecule 24 mg
Subject Sacubitril Small molecule 49 mg
Subject Sacubitril Small molecule 97 mg
Subject Valsartan Small molecule 26 mg
Subject Valsartan Small molecule 51 mg
Subject Valsartan Small molecule 103 mg