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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00071279
Recruitment Status : Completed
First Posted : October 20, 2003
Last Update Posted : April 6, 2011
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE October 16, 2003
First Posted Date  ICMJE October 20, 2003
Last Update Posted Date April 6, 2011
Study Start Date  ICMJE November 2003
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
Symptomatic recurrent PE/DVT during the 6-month study treatment period.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
Major bleeding during the 6-month study treatment period.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Condition  ICMJE
  • Pulmonary Embolism
  • Deep Vein Thrombosis
Intervention  ICMJE Drug: SR34006 (idraparinux sodium) Injection
Study Arms  ICMJE Not Provided
Publications * van Gogh Investigators, Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med. 2007 Sep 13;357(11):1105-12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2011)
1215
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Italy,   Netherlands,   New Zealand,   Norway,   Poland,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00071279
Other Study ID Numbers  ICMJE EFC5135
SR34006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP