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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00071279
Other study ID # EFC5135
Secondary ID SR34006
Status Completed
Phase Phase 3
First received October 16, 2003
Last updated April 5, 2011
Start date November 2003
Est. completion date December 2005

Study information

Verified date April 2011
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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 SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.

Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.


Recruitment information / eligibility

Status Completed
Enrollment 1215
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 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 or diastolic blood pressure > 110 mm Hg

- Pregnancy, or childbearing potential without proper contraceptive measures, women who are breastfeeding.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind


Intervention

Drug:
SR34006 (idraparinux sodium) Injection


Locations

Country Name City State
Canada University of Alberta Edmonton Alberta
Canada Kelowna General Hospital Kelowna British Columbia
Canada Jewish General Hospital Montreal Quebec
Canada The Ottawa Hospital, Civic Campus Ottawa Ontario
Canada Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec Sainte-Foy Quebec
Canada St. Paul's Hospital Vancouver British Columbia
Canada St. Boniface General Hospital Winnipeg Manitoba
United States Lovelace Sandia Health Systems, Clinical Thrombosis Center Albuquerque New Mexico
United States University of New Mexico Hospital Albuquerque New Mexico
United States Inova Alexandria Hospital Alexandria Virginia
United States Lehigh Valley Hospital Allentown Pennsylvania
United States Medical College of Georgia Augusta Georgia
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Bay Pines VA Medical Center Bay Pines Florida
United States Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office Bloomfield Hills Michigan
United States Pulmonary Associates of Brandon Brandon Florida
United States Henry Ford Hospital Detroit Michigan
United States Pulmonary Associates of Fredericksburg, Inc. Fredericksburg Virginia
United States The Methodist Hospital Houston Texas
United States Jacksonville Cardiovascular Clinic Jacksonville Florida
United States Cardinal Bernardin Cancer Center Maywood Illinois
United States Loyola University Medical Center Maywood Illinois
United States Melbourne Internal Medicine Associates (MIMA) Melbourne Florida
United States Melbourne Internal Medical Associates (MIMA) Palm Bay Florida
United States St. Joseph Mercy - Oakland Pontiac Michigan
United States St. Joseph Mercy - Oakland Clinical Research Office Pontiac Michigan
United States McGuire VA Medical Center Richmond Virginia
United States William Beaumont Hospital / Clinical Research Center Royal Oak Michigan
United States Swedish Medical Center Seattle Washington
United States Lung & Chest Medical Associates Spartanburg South Carolina
United States Spartanburg Pharmaceutical Research Spartanburg South Carolina
United States Spartanburg Regional Medical Center Spartanburg South Carolina
United States Pulmonary Specialists/Spokane Respiratory Consultants Spokane Washington
United States Sacred Heart Medical Center Spokane Washington
United States Clinical Pharmacology Services Tampa Florida
United States Scott and White Memorial Hospital and Clinic Temple Texas
United States William Beaumont Hospital Troy Troy Michigan
United States The University of Texas Health Center at Tyler Tyler Texas
United States Crozer-Chester Medical Center Upland Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Norway,  Poland,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Symptomatic recurrent PE/DVT during the 6-month study treatment period.
Secondary Major bleeding during the 6-month study treatment period.
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