Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-30 @ 8:33 AM
Study NCT ID:
NCT00442234
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2007-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism
Sponsor:
Eisai Inc.
Organization:
Study Overview
Official Title:
Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism
Status:
COMPLETED
Status Verified Date:
2010-01
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:
To investigate PK and coagulating and fibrinolytic parameter profiles (PD) at the approved dose (13,750 - 27,500 IU/kg) in patients with acute pulmonary embolism accompanying hemodynamic instability.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: