Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294086
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2006-02-17
Brief Title:
A Study of Valsartan Administered Once Daily Versus Twice Daily in Patients With Stable Chronic Heart Failure
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A 12-Week Multicenter 2-Arm Regimen Exploratory Study to Evaluate the Tolerability and Safety of Valsartan Administered Once Daily vs Daily in Patients With Stable Chronic Heart Failure NYHA Class Ll-lll
Status:
COMPLETED
Status Verified Date:
2011-06
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:
None
Brief Summary:
This study will evaluate the tolerability and safety of valsartan in patients with stable chronic heart failure NYHA Class ll-lll The 12-week double blind study has a 2-week maximum screening and a 10-week active treatment phase In each of the treatment arms QD and BID patients are up-titrated to a maximum valsartan total daily dose of 320 mg Patients remain on their prior CHF standard care therapy throughout the study period and the up-titration of valsartan is based on patient tolerability
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None