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A safety and efficacy trial evaluating the use of SanOrg34006 in the treatment of Deep Vein Thrombosis (DVT)



A safety and efficacy trial evaluating the use of SanOrg34006 in the treatment of Deep Vein Thrombosis (DVT)

For Condition: Deep Vein Thrombosis
Status: Recruiting
Sponsor(s): Sanofi-Synthelabo ,
Synopsis: 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 injectible 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 listen in the labeling of warfarin, acenocoumarol, UFH, enoxaparin, or tinzaparin
Total Enrollment: 

Location and Contact Information:

Scott and White Memorial Hospital & Clinic *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Susan  Dent 254-724-4206

Consultants in Pulmonary Medicine *Recruiting*
Olathe,  Kansas,  66061
United States
Recruiting Diane  Thorson 913-829-0446

Swedish Medical Center *Recruiting*
Seattle,  Washington,  98122
United States
Recruiting Bruce  Davidson 206-215-2500

Health System Research Center *Recruiting*
Grand Forks,  North Dakota,  58201
United States
Recruiting Dianne  Vold 701-780-1559

William Dittman *Recruiting*
Spokane,  Washington,  99203
United States
Recruiting William  Dittman 509-474-3065

DeKalb Medical Center *Recruiting*
Decatur,  Georgia,  30033-6136
United States
Recruiting Michael  Calvert 404-499-0533

Lehigh Valley Hospital *Recruiting*
Allentown,  Pennsylvania,  18103
United States
Recruiting Study  Coordinator 610-402-8999

University of Oklahoma HSC *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Penny  Razo-Mosier 405-271-4742

Boston Medical Center *Recruiting*
Boston,  Massachusetts,  02118
United States
Recruiting Jack  Ansell 617-638-7250

University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Karen  Helles 585-275-0803

North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Marjorie  Fricano 516-562-8942

MIMA Century Research Associates *Recruiting*
Melbourne,  Florida,  32901
United States
Recruiting Mima  Reseach Associate 321-723-1203

Pulmonary Associates *Recruiting*
Fredericksburg,  Virginia,  22401
United States
Recruiting Valerie  Muntem 540-372-3684

Evanston Northwestern Healthcare *Recruiting*
Evanston,  Illinois,  60201
United States
Recruiting Karen  Hathaway 847-570-1438

St. Joseph Mercy - Oakland Research Center *Recruiting*
Pontiac,  Michigan,  48341
United States
Recruiting Terri  Taylor 248-858-6767

Medical College of Georgia *Recruiting*
Augusta,  Georgia,  30912
United States
Recruiting Melissa  James 706-721-8391

James Muntz *Recruiting*
Houston,  Texas,  77030
United States
Recruiting James  Muntz 713-986-5572

Loyola University of Chicago *Recruiting*
Maywood,  Illinois,  60513
United States
Recruiting Cathy  Kalnicky 708-216-2027

University of Colorado Health Sciences Center *Recruiting*
Denver,  Colorado,  80129
United States
Recruiting Michelle  Anderson 303-315-8842

Jackson Cardio-Vascular Clinic *Recruiting*
Jacksonville,  Florida,  32216
United States
Recruiting Kim  Teeter 904-828-5573

McGuire VAMC *Recruiting*
Richmond,  Virginia,  23249
United States
Recruiting Michelle  Nichols 804-675-5000

Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting Molly  Beals 312-238-1269

Inova Alexandria Hospital *Recruiting*
Alexandria,  Virginia,  22304
United States
Recruiting James  Cooper 703-504-7950

Lovelace Health Systems *Recruiting*
Albuquerque,  New Mexico,  87108
United States
Recruiting Alex  Spyropoulous 505-262-7874


Additional Information:
Study ID Numbers:
  EFC3491/64717; 
Study Start Date: July 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067093

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