Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359801
Status:
COMPLETED
Last Update Posted:
2010-02-02
First Post:
2006-07-31
Brief Title:
Exubera Large Simple Trial To Evaluate Long-Term Pulmonary And Cardiovascular Safety
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
An International Multicenter Large Simple Trial To Evaluate The Long-Term Pulmonary And Cardiovascular Safety Of Exubera In Patients With Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2009-09
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:
VOLUME
Brief Summary:
The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice
Detailed Description:
Pfizer announced in October 2007 that it would stop marketing Exubera At that time Pfizer committed to continued marketing until it returned the licensing rights for the technology to Nektar Following the announcement enrollment was halted Subjects already enrolled and receiving treatment at the time of the halt in enrollment could continue in the study in accordance with the protocol Nektar the company from which Pfizer licensed Exubera announced on April 9 2008 that it had stopped its search for a new marketing partner Accordingly there will be no commercial availability of Exubera As a result an amendment was filed on April 16 2008 specifying that all subjects randomized to Exubera had to be transitioned to usual diabetes care and all study subjects followed for serious adverse events for 6 months In accordance with this amendment study A2171069 was terminated on April 29 2009 Neither safety nor efficacy reasons were the cause of the study termination
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