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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Pulmonary Embolism, Deep Vein Thrombosis

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC5135

NCT ID:

NCT00071279

Start Date:

November 2003

Completion Date:

December 2005

Related Keywords:

  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Embolism
  • Pulmonary Embolism
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism

Name

Location

Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Medical College of GeorgiaAugusta, Georgia  30912
Crozer-Chester Medical CenterUpland, Pennsylvania  19013
Swedish Medical CenterSeattle, Washington  98122-4307
Bay Pines VA Medical CenterSt. Petersburg, Florida  33744
Sacred Heart Medical CenterSpokane, Washington  99204
The Methodist HospitalHouston, Texas  77030
St. Joseph Mercy - OaklandPontiac, Michigan  48341
The University of Texas Health Center at TylerTyler, Texas  75708
Inova Alexandria HospitalAlexandria, Virginia  22304
Pulmonary Associates of Fredericksburg, Inc.Fredericksburg, Virginia  
McGuire VA Medical CenterRichmond, Virginia  23249
Pulmonary Associates of BrandonBrandon, Florida  
Jacksonville Cardiovascular ClinicJacksonville, Florida  
Melbourne Internal Medicine Associates (MIMA)Melbourne, Florida  
Melbourne Internal Medical Associates (MIMA)Palm Bay, Florida  
Clinical Pharmacology ServicesTampa, Florida  
Cardinal Bernardin Cancer CenterMaywood, Illinois  
Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's OfficeBloomfield Hills, Michigan  
St. Joseph Mercy - Oakland Clinical Research OfficePontiac, Michigan  
William Beaumont Hospital / Clinical Research CenterRoyal Oak, Michigan  
William Beaumont Hospital TroyTroy, Michigan  
University of New Mexico HospitalAlbuquerque, New Mexico  
Lovelace Sandia Health Systems, Clinical Thrombosis CenterAlbuquerque, New Mexico  
Spartanburg Pharmaceutical ResearchSpartanburg, South Carolina  
Lung & Chest Medical AssociatesSpartanburg, South Carolina  
Scott and White Memorial Hospital and ClinicTemple, Texas  
Pulmonary Specialists/Spokane Respiratory ConsultantsSpokane, Washington