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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191724

Purpose

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.

Condition	Intervention	Phase
Submassive Pulmonary Embolism	Drug: Drotrecogin Alfa (Activated) Drug: Enoxaparin Drug: Placebo	Phase II

MedlinePlus related topics: Blood Thinners Pulmonary Embolism

Drug Information available for: Enoxaparin Sodium Drotrecogin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Official Title:	Drotrecogin Alfa (Activated) (LY203638)] Exploratory, Safety Study, Multi-Center, Randomized, Placebo-Controlled, Dose Escalating Study Design, Comparing a Standard Therapy (Enoxaparin Sodium) for Submassive Pulmonary Embolism to a Combined Therapy of Drotrecogin Alfa (Activated) Plus Enoxaparin Sodium.

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To assess the rate of major bleeding events in the combined treatment of Drotrecogin alfa(activated) with low molecular weight heparin versus low molecular weight heparin alone in treatment of acute submassive PE [ Time Frame: baseline, day 6 +/-1, day 90 +/-7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change of right ventricular function measured as difference of RVED/LVED ratios by echocardiography [ Time Frame: baseline, day 6 +/-1, day 90 +/-7 ] [ Designated as safety issue: Yes ]
Quality of Life as measured by Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) [ Time Frame: baseline, day 6 +/-1, day 90 +/-7 ] [ Designated as safety issue: No ]
Difference in pulmonary PA pressure measured by echocardiography [ Time Frame: baseline, day 6 +/-1, day 90 +/-7 ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	September 2004
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Drotrecogin Alfa (Activated) 6 or 12 or 18 or 24 ug/kg/hr, IV, one infusion, over 12 hours Drug: Enoxaparin 1 mg/kg, subcutaneous, every 12 hours until the target INR is reached, minimum of 5 days
2: Experimental	Drug: Drotrecogin Alfa (Activated) 6 or 12 or 18 or 24 ug/kg/hr, IV, one infusion, over 12 hours Drug: Enoxaparin 1 mg/kg, subcutaneous, every 12 hours until the target INR is reached, minimum of 5 days
3: Experimental	Drug: Drotrecogin Alfa (Activated) 6 or 12 or 18 or 24 ug/kg/hr, IV, one infusion, over 12 hours Drug: Enoxaparin 1 mg/kg, subcutaneous, every 12 hours until the target INR is reached, minimum of 5 days
4: Experimental	Drug: Drotrecogin Alfa (Activated) 6 or 12 or 18 or 24 ug/kg/hr, IV, one infusion, over 12 hours Drug: Enoxaparin 1 mg/kg, subcutaneous, every 12 hours until the target INR is reached, minimum of 5 days
5: Placebo Comparator	Drug: Enoxaparin 1 mg/kg, subcutaneous, every 12 hours until the target INR is reached, minimum of 5 days Drug: Placebo IV, one infusion, over 12 hours

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with symptoms of acute 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191724

Locations

Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mannheim, Germany

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	8354, F1K-MC-O014
Study First Received:	September 12, 2005
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00191724
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Drotrecogin alfa activated
Embolism and Thrombosis
Pulmonary Embolism
Protein C
Respiratory Tract Diseases

Embolism
Lung Diseases
Vascular Diseases
Thrombosis
Enoxaparin

Additional relevant MeSH terms:

Anti-Infective Agents
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009