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Home > "A" Clinical Trials Conditions > A safety and efficacy trial evaluating the use of SanOrg34006 in the treatment of pulmonary embolism

A safety and efficacy trial evaluating the use of SanOrg34006 in the treatment of pulmonary embolism



A safety and efficacy trial evaluating the use of SanOrg34006 in the treatment of pulmonary embolism

For Condition: Pulmonary Embolism
Status: Recruiting
Sponsor(s): Organon ,
Synopsis: Patients who have a pulmonary embolism (blood clot in the lung) 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, SanOrg34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Assignment to either SanOrg34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT) - Written informed consent Exclusion Criteria: - Legal lower age limitations (country specific) - Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE - Other indication for VKA than PE/DVT - More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)heparin or initiation of VKA treatment prior to randomization - Participation in another pharmacotherapeutic study within the prior 30 days - Creatinine clearance <10 mL/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, enoxaparin, or tinzaparin
Total Enrollment: 

Location and Contact Information:

Hamilton Health Sciences - General Hospital *Recruiting*
Hamilton,  Ontario, 
Canada
Recruiting  

William Beaumont Hospital *Recruiting*
Royal Oak,  Michigan,  48073
United States
Recruiting  

Swedish Medical Center *Recruiting*
Seattle,  Washington,  98122
United States
Recruiting  

Baptist Memorial Hospital Memphis *Recruiting*
Memphis,  Tennessee, 
United States
Recruiting  

INTEGRIS Southwest Medical Center *Recruiting*
Oklahoma City,  Oklahoma,  73109
United States
Recruiting  

Inova Alexandria Hospital *Recruiting*
Alexandria,  Virginia,  22304
United States
Recruiting  

University of North Carolina Hospitals *Recruiting*
Chapel Hill,  North Carolina,  27599
United States
Recruiting  

Boston Medical Center *Recruiting*
Boston,  Massachusetts, 
United States
Recruiting  

Lovelace Health Systems, Clinical Thrombosis Center *Recruiting*
Albuquerque,  New Mexico,  87108
United States
Recruiting  

Spartanburg Regional Medical Center *Recruiting*
Spartanburg,  South Carolina,  23903
United States
Recruiting  

Olathe Medical Center *Recruiting*
Olathe,  Kansas, 
United States
Recruiting  

The University of Texas Health Center at Tyler *Recruiting*
Tyler,  Texas,  75708
United States
Recruiting  

Sinai Hospital of Baltimore *Recruiting*
Baltimore,  Maryland, 
United States
Recruiting  

Scott & White Memorial Hospital & Clinic *Recruiting*
Temple,  Texas,  76508
United States
Recruiting  

Pulmonary Associates of Fredericksburg, Inc. *Recruiting*
Fredericksburg,  Virginia, 
United States
Recruiting  

OU Medical Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting  

University of Colorado Hospital *Recruiting*
Denver,  Colorado, 
United States
Recruiting  

Jerry L. Pettic VA Medical Center *Recruiting*
Loma Linda,  California, 
United States
Recruiting  

Oklahoma City VA Medical Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting  

The Methodist Hospital *Recruiting*
Houston,  Texas,  77030
United States
Recruiting  

St. Boniface General Hospital *Recruiting*
Winnipeg,  Manitoba,  R2H 2A6
Canada
Recruiting  

McGuire VA Medical Center *Recruiting*
Richmond,  Virginia,  23249
United States
Recruiting  

Mary Black Memorial Hospital *Recruiting*
Spartanburg,  South Carolina,  29307
United States
Recruiting  

Saint Anthony Hospital *Recruiting*
Oklahoma City,  Oklahoma,  73101
United States
Recruiting  

Jackson Memorial Hospital *Recruiting*
Miami,  Florida,  33136
United States
Recruiting  

Winthrop Pulmonary Associates *Recruiting*
Mineola,  New York,  11501
United States
Recruiting  

William Beaumont Hospital *Recruiting*
Troy,  Michigan,  48085
United States
Recruiting  

Kelowna General Hospital *Recruiting*
Kelowna,  British Columbia,  V1Y 1T2
Canada
Recruiting  

Riverside Methodist Hospital *Recruiting*
Columbus,  Ohio,  43214
United States
Recruiting  

University Hospital *Recruiting*
Salt Lake City,  Utah, 
United States
Recruiting  

Sacred Heart Medical Center *Recruiting*
Spokane,  Washington,  99220
United States
Recruiting  

Jewish General Hospital *Recruiting*
Montreal,  Quebec, 
Canada
Recruiting  

University of Alberta Hospital *Recruiting*
Edmonton,  Alberta,  T6G 2B7
Canada
Recruiting  

Henry Ford Hospital *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting  

University of California, San Diego Medical Center *Recruiting*
San Diego,  California, 
United States
Recruiting  

Altru Health System Hospital *Recruiting*
Grand Forks,  North Dakota,  58201
United States
Recruiting  

Akron General Medical Center *Recruiting*
Akron,  Ohio,  44307
United States
Recruiting  

DeKalb Medical Center *Recruiting*
Decatur,  Georgia,  30033
United States
Recruiting  

Ottawa Hospital - Civic Campus *Recruiting*
Ottawa,  Ontario,  K1Y 4E9
Canada
Recruiting  

St. Joseph Mercy - Oakland *Recruiting*
Pontiac,  Michigan,  48341
United States
Recruiting  

Medical College of Georgia *Recruiting*
Augusta,  Georgia,  30912
United States
Recruiting  

London Health Sciences Centre *Recruiting*
London,  Ontario,  N6A 4G5
Canada
Recruiting  

Winthrop University Hospital *Recruiting*
Mineola,  New York,  11501
United States
Recruiting  

Holmes Regional Medical Center *Recruiting*
Melbourne,  Florida,  32901
United States
Recruiting  

Christus St. Patrick Hospital *Recruiting*
Lake Charles,  Louisiana,  70601
United States
Recruiting  

Loyola University Medical Center and Outpatient Clinic *Recruiting*
Maywood,  Illinois,  60153
United States
Recruiting  

Northwest Texas Healthcare System *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting  

Mount Sinai School of Medicine *Recruiting*
New York City,  New York, 
United States
Recruiting  

St. Joseph's Hospital *Recruiting*
Tampa,  Florida,  33607
United States
Recruiting  

Anschutz Cancer Pavilion *Recruiting*
Aurora,  Colorado, 
United States
Recruiting  

QEII Health Sciences Center *Recruiting*
Halifax,  Nova Scotia,  B3H 2Y9
Canada
Recruiting  

Brandon Regional Hospital *Recruiting*
Brandon,  Florida,  33511
United States
Recruiting  

Crozer-Chester Medical Center *Recruiting*
Upland,  Pennsylvania,  19013
United States
Recruiting  

Medical College of Ohio *Recruiting*
Toledo,  Ohio,  43614
United States
Recruiting  

University Health Network, Toronto General Hospital *Recruiting*
Toronto,  Ontario, 
Canada
Recruiting  

Lehigh Valley Hospital *Recruiting*
Allentown,  Pennsylvania,  18105
United States
Recruiting  

St. Paul's Hospital *Recruiting*
Vancouver,  British Columbia, 
Canada
Recruiting  

Baystate Medical Center *Recruiting*
Springfield,  Massachusetts,  01199
United States
Recruiting  

The West Cancer Clinic *Recruiting*
Memphis,  Tennessee, 
United States
Recruiting  

Bay Pines VA Medical Center *Recruiting*
Bay Pines,  Florida,  33744
United States
Recruiting  


Additional Information:
Study ID Numbers:
  64714/EFC3484; 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062803

Other Pulmonary Embolism Studies:
1. A safety and efficacy trial evaluating the use of SanOrg34006 in the treatment of pulmonary embolism

2. Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED II)

3. Nurses' Health Study

4. A safety and efficacy trial evaluating the use of SanOrg34006 compared to placebo in patients who have completed 6 months of treatment for symptomatic pulmonary embolism or deep vein thrombosis

5. Risk Factors for Venous Thromboembolism

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A safety and efficacy trial evaluating the use of SanOrg34006 in the treatment of pulmonary embolism

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