SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis

April 5, 2011 updated by: Sanofi

The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1215

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Box Hill, Clayton, Coffs Harbour, Garran, Kogarah, Australia
      • Premantle, Redcliffe, St. Leonards, South Australia, Australia
      • Ringwood East, Woolloongabba, Australia
  • Austria
      • Graz, Wien, Austria
  • Belgium
      • Bruxelles, Duffel, Leuven, Lier, Zottegem, Belgium
  • Brazil
      • Porto Alegre, Salvador, Sao Paulo, Brazil
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Kelowna General Hospital
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • St. Boniface General Hospital
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital, Civic Campus
    • Quebec
      • Montreal, Quebec, Canada
        • Jewish General Hospital
      • Sainte-Foy, Quebec, Canada
        • Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec
  • Czech Republic
      • Brno, Hradec Karlove, Jihlava, Karlovy Vary, Kladno, Czech Republic
      • Ostrava-Poruba, Plzen, Prague, Usti nad Labem, Czech Republic
  • Denmark
      • Arhus, Braedstrup, Frederiksberg, Glostrup, Hillerod, Denmark
      • Kobenhavn, Odense, Denmark
  • Finland
      • Seinajoki, Finland
  • France
      • Besancon, Brest, Chambray les Tours, Clamart, Grenoble, France
      • Montpellier, Paris, Rouen, Saint Brieuc, Saint Etienne, France
      • Toulouse, Valenciennes, France
  • Germany
      • Berlin, Bochum, Dresden, Heidelberg, Ibbenburen, Mannheim, Germany
  • Italy
      • Genova, Milano, Padova, Parma, Pavia, Piacenza, Reggio Emilia, Italy
      • Treviso, Venezia, Italy
  • Netherlands
      • Alkmaar, Almere, Amersfoort, Amsterdam, Arnhem, Haarlem, Netherlands
      • Maastricht, Nieuwegein, Sittard, Zwolle, Netherlands
  • New Zealand
      • Auckland, New Zealand
  • Norway
      • Oslo, Rud, Norway
  • Poland
      • Bialystok, Szczecin, Warszawa, Wroclaw, Poland
  • South Africa
      • Bloemfontein, Bryanston, Durban, South Africa
  • Spain
      • Barcelona, Madrid, Torrelavega, Xativa, Spain
  • Sweden
      • Goteborg, Jonkoping, Stockholm, Varnamo, Vastervik, Sweden
  • United Kingdom
      • London, United Kingdom
  • United States
    • Florida
      • Bay Pines, Florida, United States
        • Bay Pines VA Medical Center
      • Brandon, Florida, United States
        • Pulmonary Associates of Brandon
      • Jacksonville, Florida, United States
        • Jacksonville Cardiovascular Clinic
      • Melbourne, Florida, United States
        • Melbourne Internal Medicine Associates (Mima)
      • Palm Bay, Florida, United States
        • Melbourne Internal Medical Associates (MIMA)
      • Tampa, Florida, United States
        • Clinical Pharmacology Services
    • Georgia
      • Augusta, Georgia, United States
        • Medical College of Georgia
    • Illinois
      • Maywood, Illinois, United States
        • Loyola University Medical Center
      • Maywood, Illinois, United States
        • Cardinal Bernardin Cancer Center
    • Maryland
      • Baltimore, Maryland, United States
        • Sinai Hospital of Baltimore
    • Michigan
      • Bloomfield Hills, Michigan, United States
        • Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office
      • Detroit, Michigan, United States
        • Henry Ford Hospital
      • Pontiac, Michigan, United States
        • St. Joseph Mercy - Oakland Clinical Research Office
      • Pontiac, Michigan, United States
        • St. Joseph Mercy - Oakland
      • Royal Oak, Michigan, United States
        • William Beaumont Hospital / Clinical Research Center
      • Troy, Michigan, United States
        • William Beaumont Hospital Troy
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Lovelace Sandia Health Systems, Clinical Thrombosis Center
      • Albuquerque, New Mexico, United States
        • University of New Mexico Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Lehigh Valley Hospital
      • Upland, Pennsylvania, United States
        • Crozer-Chester Medical Center
    • South Carolina
      • Spartanburg, South Carolina, United States
        • Lung & Chest Medical Associates
      • Spartanburg, South Carolina, United States
        • Spartanburg Pharmaceutical Research
      • Spartanburg, South Carolina, United States
        • Spartanburg Regional Medical Center
    • Texas
      • Houston, Texas, United States
        • The Methodist Hospital
      • Temple, Texas, United States
        • Scott and White Memorial Hospital and Clinic
      • Tyler, Texas, United States
        • The University of Texas Health Center at Tyler
    • Virginia
      • Alexandria, Virginia, United States
        • Inova Alexandria Hospital
      • Fredericksburg, Virginia, United States
        • Pulmonary Associates of Fredericksburg, Inc.
      • Richmond, Virginia, United States
        • McGuire VA Medical Center
    • Washington
      • Seattle, Washington, United States
        • Swedish Medical Center
      • Spokane, Washington, United States
        • Pulmonary Specialists/Spokane Respiratory Consultants
      • Spokane, Washington, United States
        • Sacred Heart Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Symptomatic recurrent PE/DVT during the 6-month study treatment period.

Secondary Outcome Measures

Outcome Measure
Major bleeding during the 6-month study treatment period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

October 16, 2003

First Submitted That Met QC Criteria

October 17, 2003

First Posted (Estimate)

October 20, 2003

Study Record Updates

Last Update Posted (Estimate)

April 6, 2011

Last Update Submitted That Met QC Criteria

April 5, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5135
  • SR34006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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