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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191724
First received: September 12, 2005
Last updated: June 16, 2009
Last verified: June 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:

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
Experimental: 1 Drug: Drotrecogin Alfa (Activated)
6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
Other Name: Xigris, LY203638
Drug: Enoxaparin
1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days
Experimental: 2 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
Other Name: Xigris, LY203638
Experimental: 3 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
Other Name: Xigris, LY203638
Experimental: 4 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
Other Name: Xigris, LY203638
Placebo Comparator: 5 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 by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Enoxaparin
Protein C
Drotrecogin alfa activated
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 16, 2013