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

Submassive Pulmonary Embolism Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191724
• Other study ID #: 8354
• Secondary ID: F1K-MC-O014
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: June 16, 2009
• Start date: September 2004
• Est. completion date: January 2008

Study information

• Verified date: June 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Submassive Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Major Bleeding Events		baseline through day 6	Yes
Secondary	Right Ventricular Enddiastolic Area/Left Ventricular Enddiastolic Area (RVEDA/LVEDA) Ratios		baseline, day 6, day 90	Yes
Secondary	Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS of the McMaster University Canada)		baseline and day 90 (follow-up)	No
Secondary	Difference in Pulmonary Artery (PA) Pressure		baseline, day 6, day 90	Yes

External Links

•   Lilly Clinical Trial Registry