Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study

Lilly

Status and phase

Completed

Phase 2

Conditions

Submassive Pulmonary Embolism

Treatments

Drug: Drotrecogin Alfa (Activated)

Drug: Enoxaparin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191724

F1K-MC-O014

8354

Details and patient eligibility

About

An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.

Enrollment

47 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients with symptoms of acute pulmonary embolism (PE), without an indication for fibrinolytic therapy but with echocardiographic evidence of right ventricular dysfunction (submassive PE) within 48 hours of onset of symptoms

Inclusion Criteria:

Clinical symptoms of Pulmonary embolism for less than 48 hours

Exclusion Criteria:

Patients with symptoms of Pulmonary embolism for more than 48 hours

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

47 participants in 5 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Enoxaparin

Drug: Drotrecogin Alfa (Activated)

2

Experimental group

Treatment:

Drug: Enoxaparin

Drug: Drotrecogin Alfa (Activated)

3

Experimental group

Treatment:

Drug: Enoxaparin

Drug: Drotrecogin Alfa (Activated)

4

Experimental group

Treatment:

Drug: Enoxaparin

Drug: Drotrecogin Alfa (Activated)

5

Placebo Comparator group

Treatment:

Drug: Enoxaparin

Drug: Placebo

Trial contacts and locations

1

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