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Deep Vein ThrombosisPhase 3NCT00067093

Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)

A Phase 3 study testing SanOrg34006, LMW heparin and Unfractionated heparin in people with Deep Vein Thrombosis, run by Sanofi at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Deep Vein Thrombosis
What is being tested?
SanOrg34006, LMW heparin and Unfractionated heparin
How many people
1,452 participants
Where
24 sitesUnited States
Study dates
May 2003to Sep 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed acute symptomatic DVT
  • Written informed consent

Who cannot join

  • Legal lower age limitations
  • Patients with symptomatic pulmonary embolism
  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
  • Other indication for VKA than DVT
  • More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization
  • Participation in another pharmacotherapeutic study within the prior 30 days
Show all 12Show fewer
  • Creatinine clearance <10mL/min, severe hepatic disease or bacterial endocarditis
  • Life expectancy <3 Months
  • Active bleeding or high risk for bleeding
  • Uncontrolled hypertension: systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg.
  • Pregnancy or childbearing potential without proper contraceptive measures
  • Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Lovelace Health Systems

    Albuquerque, New Mexico, 87108

  • Inova Alexandria Hospital

    Alexandria, Virginia, 22304

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Northwestern University

    Chicago, Illinois, 60611

  • DeKalb Medical Center

    Decatur, Georgia, 30033-6136

  • University of Colorado Health Sciences Center

    Denver, Colorado, 80129

  • Evanston Northwestern Healthcare

    Evanston, Illinois, 60201

  • Pulmonary Associates

    Fredericksburg, Virginia, 22401

  • Health System Research Center

    Grand Forks, North Dakota, 58201

  • James Muntz

    Houston, Texas, 77030

  • Jackson Cardio-Vascular Clinic

    Jacksonville, Florida, 32216

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Loyola University of Chicago

    Maywood, Illinois, 60513

  • MIMA Century Research Associates

    Melbourne, Florida, 32901

  • University of Oklahoma HSC

    Oklahoma City, Oklahoma, 73104

  • Consultants in Pulmonary Medicine

    Olathe, Kansas, 66061

  • St. Joseph Mercy - Oakland Research Center

    Pontiac, Michigan, 48341

  • McGuire VAMC

    Richmond, Virginia, 23249

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Swedish Medical Center

    Seattle, Washington, 98122

  • William Dittman

    Spokane, Washington, 99203

  • Scott and White Memorial Hospital & Clinic

    Temple, Texas, 76508

Other trials in United States

About this study

Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.

Being tested
SanOrg34006, LMW heparin, Unfractionated heparin, Vitamin K antagonist (VKA)
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SanOrg34006Drug

  • LMW heparinDrug

  • Unfractionated heparinDrug

  • Vitamin K antagonist (VKA)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months

Secondary outcomes (1)

  1. symptomatic recurrent PE/DVT within 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2003 (estimated)
  2. Study startMay 2003
  3. Primary completionSep 2005
  4. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00067093
Sponsor's protocol ID
EFC3491
Other IDs
SR34006
Status last verified
Apr 2011
First submitted
11 Aug 2003
Last updated
6 Apr 2011
Results posted
No

Publications

  • Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.

    PubMed 19348685

  • van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007 Sep 13;357(11):1094-104. doi: 10.1056/NEJMoa064247.

    PubMed 17855670

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SanOrg34006, LMW heparin and Unfractionated heparin in people with Deep Vein Thrombosis, run by Sanofi at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00067093, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2011.

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