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

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.

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Embolism

Drug Information available for: Drotrecogin alfa Enoxaparin Sodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Number of Participants With Major Bleeding Events [ Time Frame: baseline through day 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios [ Time Frame: baseline, day 6, day 90 ] [ Designated as safety issue: Yes ]
Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada) [ Time Frame: baseline and day 90 (follow-up) ] [ Designated as safety issue: No ]
Difference in Pulmonary Artery (PA) Pressure [ Time Frame: baseline, day 6, day 90 ] [ Designated as safety issue: Yes ]

Enrollment:	47
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 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours Drug: Enoxaparin 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days
2: Experimental	Drug: Enoxaparin 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days Drug: Drotrecogin Alfa (Activated) 12 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
3: Experimental	Drug: Enoxaparin 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days Drug: Drotrecogin Alfa (Activated) 18 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
4: Experimental	Drug: Enoxaparin 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days Drug: Drotrecogin Alfa (Activated) 24 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
5: Placebo Comparator	Drug: Enoxaparin 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days Drug: Placebo intravenous (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 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

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

Additional Information:

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

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	8354, F1K-MC-O014
Study First Received:	September 12, 2005
Results First Received:	January 14, 2009
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00191724 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Anti-Infective Agents
Drotrecogin alfa activated
Pulmonary Embolism
Anticoagulants
Vascular Diseases
Adjuvants, Immunologic
Fibrinolytic Agents
Cardiovascular Agents

Thrombosis
Enoxaparin
Fibrin Modulating Agents
Embolism and Thrombosis
Respiratory Tract Diseases
Protein C
Embolism
Lung Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Drotrecogin alfa activated
Pulmonary Embolism
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

Enoxaparin
Fibrin Modulating Agents
Embolism and Thrombosis
Respiratory Tract Diseases
Protein C
Embolism
Lung Diseases
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 02, 2009