drugset / Trial / NCT00442234

Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism

NCT00442234 ↗

Phase 4 Completed 5 enrolled Eisai Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-05-01
Primary completion
2008-04-01
Completion
2008-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Monteplase Protein / enzyme biologic 13750 iu/kg —
Subject Monteplase Protein / enzyme biologic 27500 iu/kg —

Indications