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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00071279




Registration number
NCT00071279
Ethics application status
Date submitted
16/10/2003
Date registered
20/10/2003
Date last updated
6/04/2011

Titles & IDs
Public title
SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
Scientific title
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
Secondary ID [1] 0 0
SR34006
Secondary ID [2] 0 0
EFC5135
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 0 0
Deep Vein Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Symptomatic recurrent PE/DVT during the 6-month study treatment period.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Major bleeding during the 6-month study treatment period.
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
1215
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Box Hill, Clayton, Coffs Harbour, Garran, Kogarah
Recruitment hospital [2] 0 0
- Premantle, Redcliffe, St. Leonards, South Australia
Recruitment hospital [3] 0 0
- Ringwood East, Woolloongabba
Recruitment postcode(s) [1] 0 0
- Box Hill, Clayton, Coffs Harbour, Garran, Kogarah
Recruitment postcode(s) [2] 0 0
- Premantle, Redcliffe, St. Leonards, South Australia
Recruitment postcode(s) [3] 0 0
- Ringwood East, Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Austria
State/province [12] 0 0
Graz, Wien
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles, Duffel, Leuven, Lier, Zottegem
Country [14] 0 0
Brazil
State/province [14] 0 0
Porto Alegre, Salvador, Sao Paulo
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Brno, Hradec Karlove, Jihlava, Karlovy Vary, Kladno
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Ostrava-Poruba, Plzen, Prague, Usti nad Labem
Country [22] 0 0
Denmark
State/province [22] 0 0
Arhus, Braedstrup, Frederiksberg, Glostrup, Hillerod
Country [23] 0 0
Denmark
State/province [23] 0 0
Kobenhavn, Odense
Country [24] 0 0
Finland
State/province [24] 0 0
Seinajoki
Country [25] 0 0
France
State/province [25] 0 0
Besancon, Brest, Chambray les Tours, Clamart, Grenoble
Country [26] 0 0
France
State/province [26] 0 0
Montpellier, Paris, Rouen, Saint Brieuc, Saint Etienne
Country [27] 0 0
France
State/province [27] 0 0
Toulouse, Valenciennes
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin, Bochum, Dresden, Heidelberg, Ibbenburen, Mannheim
Country [29] 0 0
Italy
State/province [29] 0 0
Genova, Milano, Padova, Parma, Pavia, Piacenza, Reggio Emilia
Country [30] 0 0
Italy
State/province [30] 0 0
Treviso, Venezia
Country [31] 0 0
Netherlands
State/province [31] 0 0
Alkmaar, Almere, Amersfoort, Amsterdam, Arnhem, Haarlem
Country [32] 0 0
Netherlands
State/province [32] 0 0
Maastricht, Nieuwegein, Sittard, Zwolle
Country [33] 0 0
New Zealand
State/province [33] 0 0
Auckland
Country [34] 0 0
Norway
State/province [34] 0 0
Oslo, Rud
Country [35] 0 0
Poland
State/province [35] 0 0
Bialystok, Szczecin, Warszawa, Wroclaw
Country [36] 0 0
South Africa
State/province [36] 0 0
Bloemfontein, Bryanston, Durban
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona, Madrid, Torrelavega, Xativa
Country [38] 0 0
Sweden
State/province [38] 0 0
Goteborg, Jonkoping, Stockholm, Varnamo, Vastervik
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00071279