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Sponsors and Collaborators: |
Eisai Inc. Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00442234 |
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.
Condition | Intervention | Phase |
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Pulmonary Embolism |
Drug: Monteplase |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism |
Estimated Enrollment: | 4 |
Study Start Date: | February 2007 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1) Patients who consent for study participation and submit written informed consent with free will by patient or legally authorized representative.
2) Patients aged between 20 years or above and under 75 years old at the time of obtaining informed consent.
3) Patients with acute pulmonary embolism within 5 days after the onset.
4) Patients with acute pulmonary embolism with hemodynamic instability and fulfill all of the following 4 items:
Confirmed to have any of the following right ventricular overloads by echocardiography:
i) Dilation of right ventricular cavity or hypokinesis in ventricular wall
ii) Floating thrombi in pulmonary artery and right heart
iii) Paradoxical motion in the interventricular septum
iv) Disparity of tricuspid regurgitation pressure
v) Loss of inrespiratory changes of inferior vena cava in diameter
vi) Enlargement of pulmonary artery
Exclusion Criteria:
Japan, Kanagawa | |
Yokohama, Kanagawa, Japan, 245-8575 | |
Japan, Tokyo | |
Bunkyo-ku, Tokyo, Japan, 113-8603 |
Study Director: | Takashi Musha | Department Marketed Product Research, Clinical Research Center |
Study ID Numbers: | E6010-J081-591 |
Study First Received: | February 27, 2007 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00442234 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Acute pulmonary embolism |
accompanying hemodynamic instability |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism |
Lung Diseases Vascular Diseases Thrombosis |
Cardiovascular Diseases |