Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063687
Status:
COMPLETED
Last Update Posted:
2005-08-05
First Post:
2003-07-02
Brief Title:
Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure
Sponsor:
Advanz Pharma
Organization:
Advanz Pharma
Study Overview
Official Title:
A Phase II-III Prospective Randomized Double-Blind Placebo-Controlled Efficacy and Safety Study of Oxypurinol Added to Standard Therapy in Patients With NYHA Class III-IV Congestive Heart Failure
Status:
COMPLETED
Status Verified Date:
2003-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The OPT-CHF OxyPurinol Therapy for CHF study is designed to demonstrate the efficacy and safety of oral oxypurinol vs placebo in a randomized double-blind twenty-four week trial in 400 patients in up to 50 centers Measures of clinical efficacy NYHA class and Patient Global Assessment as well as clinical outcomes eg death worsening heart failure and hospitalization will be assessed as a composite endpoint in this trial
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