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Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)

Primary Purpose

Deep Vein Thrombosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SanOrg34006
LMW heparin
Unfractionated heparin
Vitamin K antagonist (VKA)
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed acute symptomatic DVT Written informed consent Exclusion Criteria: Legal lower age limitations Patients with symptomatic pulmonary embolism Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT Other indication for VKA than DVT More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization Participation in another pharmacotherapeutic study within the prior 30 days Creatinine clearance <10mL/min, severe hepatic disease or bacterial endocarditis Life expectancy <3 Months Active bleeding or high risk for bleeding Uncontrolled hypertension: systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg. Pregnancy or childbearing potential without proper contraceptive measures Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin

Sites / Locations

  • University of Colorado Health Sciences Center
  • Jackson Cardio-Vascular Clinic
  • MIMA Century Research Associates
  • Medical College of Georgia
  • DeKalb Medical Center
  • Northwestern University
  • Evanston Northwestern Healthcare
  • Loyola University of Chicago
  • Consultants in Pulmonary Medicine
  • Boston Medical Center
  • St. Joseph Mercy - Oakland Research Center
  • Lovelace Health Systems
  • North Shore University Hospital
  • University of Rochester Medical Center
  • Health System Research Center
  • University of Oklahoma HSC
  • Lehigh Valley Hospital
  • James Muntz
  • Scott and White Memorial Hospital & Clinic
  • Inova Alexandria Hospital
  • Pulmonary Associates
  • McGuire VAMC
  • Swedish Medical Center
  • William Dittman

Outcomes

Primary Outcome Measures

symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months

Secondary Outcome Measures

symptomatic recurrent PE/DVT within 6 months.

Full Information

First Posted
August 11, 2003
Last Updated
April 5, 2011
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00067093
Brief Title
Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1452 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SanOrg34006
Intervention Type
Drug
Intervention Name(s)
LMW heparin
Intervention Type
Drug
Intervention Name(s)
Unfractionated heparin
Intervention Type
Drug
Intervention Name(s)
Vitamin K antagonist (VKA)
Primary Outcome Measure Information:
Title
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
Secondary Outcome Measure Information:
Title
symptomatic recurrent PE/DVT within 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed acute symptomatic DVT Written informed consent Exclusion Criteria: Legal lower age limitations Patients with symptomatic pulmonary embolism Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT Other indication for VKA than DVT More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization Participation in another pharmacotherapeutic study within the prior 30 days Creatinine clearance <10mL/min, severe hepatic disease or bacterial endocarditis Life expectancy <3 Months Active bleeding or high risk for bleeding Uncontrolled hypertension: systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg. Pregnancy or childbearing potential without proper contraceptive measures Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80129
Country
United States
Facility Name
Jackson Cardio-Vascular Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
MIMA Century Research Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
DeKalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-6136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Loyola University of Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60513
Country
United States
Facility Name
Consultants in Pulmonary Medicine
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
St. Joseph Mercy - Oakland Research Center
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Lovelace Health Systems
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Health System Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
University of Oklahoma HSC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
James Muntz
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott and White Memorial Hospital & Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Inova Alexandria Hospital
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Pulmonary Associates
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
McGuire VAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
William Dittman
City
Spokane
State/Province
Washington
ZIP/Postal Code
99203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19348685
Citation
Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.
Results Reference
derived
PubMed Identifier
17855670
Citation
van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007 Sep 13;357(11):1094-104. doi: 10.1056/NEJMoa064247.
Results Reference
derived
Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

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Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)

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