Ignite Creation Date:
2024-05-06 @ 8:15 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02690974
Status:
COMPLETED
Last Update Posted:
2019-06-07
First Post:
2016-02-15
Brief Title:
Description of Tolerability of LCZ696 Sacubitril Valsartan in Heart Failure With Reduced Ejection Fraction HFrEF Treated in Real Life Setting
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Prospective Multi-center Open lAbel Post-appRovAl Study AImed at Characterizing the Use of LCZ696 at 97 mg Sacubitril 103 mg Valsartan Bid in Patients With HFrEF
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARASAIL
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None