Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00162955
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2005-09-09
Brief Title:
Prevention of CHOP-induced Chronic Cardiotoxicity
Sponsor:
Osaka City University
Organization:
Osaka City University
Study Overview
Official Title:
The Multi-centers Trial for Patients With Non-Hodgkins Lymphoma to Assess the Protective Effect of Valsartan on Chronic Cardiotoxicity Induced by CHOP
Status:
COMPLETED
Status Verified Date:
2010-09
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:
The purpose of this study is to assess the protective effect of Valsartan on chronic cardiotoxicity induced by CHOP
Detailed Description:
Doxorubicin has been one of the most important key drugs in treatment for malignancies However its use is limited by dose-dependent cumulative cardiotoxicity This multi-centers trial was designed to investigate the preventive effect of Valsartan the angiotensin II type 1 receptor blocker ARB on chronic cardiotoxicity due to doxorubicin based chemotherapy Patients with untreated non-Hodgkins lymphoma who are scheduled to receive at least 6 courses of the standard CHOP -R will be randomized by the minimization methods to the treatment group with Valsartan 80mg once daily by oral during entire 6 courses of CHOP or control group Cardiac function will be evaluated in detail before and after 3 and 6 courses of CHOP -R
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