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

NCT00442234 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-10-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Monteplase

Sponsors & Collaborators

  • Eisai Co., Ltd.

    collaborator INDUSTRY

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Takashi Musha · Department Marketed Product Research, Clinical Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00442234 on ClinicalTrials.gov