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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 Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on 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 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like 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. 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 Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Subjects typically recieve the finest healthcare available for their 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 condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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 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
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
For Condition: Deep Vein Thrombosis,Pulmonary Embolism
Status: Recruiting
Sponsor(s): Organon ,
Synopsis: Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur. In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SanOrg34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SanOrg34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SanOrg34006 have fewer recurrences of blood clots when compared to patients treated with placebo. Assignment to either SanOrg34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.
Details:
Eligibility:
Study Type: Interventional, Randomized, Double-Blind, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SanOrg34006 for six months - Written informed consent Exclusion Criteria: - Legal age limitations (country specific) - Indication for anticoagulation other than PE or DVT - Creatinine clearance (CLcr) <10 mL/min, severe hepatic disease, or bacterial endocarditis - Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days - Life expectancy <3 months - Patients in whom anticoagulation treatment for their index PE or DVT should be continued beyond 6 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
Total Enrollment:
Location and Contact Information:
Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec *Recruiting*
Sainte-Foy, Quebec,
Canada
Recruiting
Scott and White Memorial Hospital and Clinic *Recruiting*
Temple, Texas,
United States
Recruiting
Medical College of Georgia *Recruiting*
Augusta, Georgia,
United States
Recruiting
William Beaumont Hospital Troy *Recruiting*
Troy, Michigan,
United States
Recruiting
The Methodist Hospital *Recruiting*
Houston, Texas,
United States
Recruiting
Inova Alexandria Hospital *Recruiting*
Alexandria, Virginia,
United States
Recruiting
University of New Mexico Hospital *Recruiting*
Albuquerque, New Mexico,
United States
Recruiting
University of Alberta *Recruiting*
Edmonton, Alberta,
Canada
Recruiting
Pulmonary Associates of Brandon *Recruiting*
Brandon, Florida,
United States
Recruiting
St. Joseph Mercy - Oakland Clinical Research Office *Recruiting*
Pontiac, Michigan,
United States
Recruiting
Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office *Recruiting*
Bloomfield Hills, Michigan,
United States
Recruiting
Loyola University Medical Center *Recruiting*
Maywood, Illinois,
United States
Recruiting
Clinical Pharmacology Services *Recruiting*
Tampa, Florida,
United States
Recruiting
St. Joseph Mercy - Oakland *Recruiting*
Pontiac, Michigan,
United States
Recruiting
Swedish Medical Center *Recruiting*
Seattle, Washington,
United States
Recruiting
St. Boniface General Hospital *Recruiting*
Winnipeg, Manitoba,
Canada
Recruiting
Cardinal Bernardin Cancer Center *Recruiting*
Maywood, Illinois,
United States
Recruiting
Melbourne Internal Medical Associates (MIMA) *Recruiting*
Palm Bay, Florida,
United States
Recruiting
Bay Pines VA Medical Center *Recruiting*
Bay Pines, Florida,
United States
Recruiting
Sinai Hospital of Baltimore *Recruiting*
Baltimore, Maryland,
United States
Recruiting
McGuire VA Medical Center *Recruiting*
Richmond, Virginia,
United States
Recruiting
Crozer-Chester Medical Center *Recruiting*
Upland, Pennsylvania,
United States
Recruiting
St. Paul's Hospital *Recruiting*
Vancouver, British Columbia,
Canada
Recruiting
Kelowna General Hospital *Recruiting*
Kelowna, British Columbia,
Canada
Recruiting
Lovelace Sandia Health Systems, Clinical Thrombosis Center *Recruiting*
Albuquerque, New Mexico,
United States
Recruiting
Melbourne Internal Medicine Associates (MIMA) *Recruiting*
Melbourne, Florida,
United States
Recruiting
Spartanburg Pharmaceutical Research *Recruiting*
Spartanburg, South Carolina,
United States
Recruiting
Spartanburg Regional Medical Center *Recruiting*
Spartanburg, South Carolina,
United States
Recruiting
Lung & Chest Medical Associates *Recruiting*
Spartanburg, South Carolina,
United States
Recruiting
Henry Ford Hospital *Recruiting*
Detroit, Michigan,
United States
Recruiting
Pulmonary Associates of Fredericksburg, Inc. *Recruiting*
Fredericksburg, Virginia,
United States
Recruiting
Lehigh Valley Hospital *Recruiting*
Allentown, Pennsylvania,
United States
Recruiting
Pulmonary Specialists/Spokane Respiratory Consultants *Recruiting*
Spokane, Washington,
United States
Recruiting
Jacksonville Cardiovascular Clinic *Recruiting*
Jacksonville, Florida,
United States
Recruiting
The University of Texas Health Center at Tyler *Recruiting*
Tyler, Texas,
United States
Recruiting
Additional Information:
Study ID Numbers: 64721/EFC5135;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071279
Other Deep Vein Thrombosis 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. Risk Factors for Venous Thromboembolism
5. 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
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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
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