SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
Public ClinicalTrials.gov record NCT00071279. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00071279
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,215 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2003
- Primary completion
- Nov 30, 2005
- Completion
- Nov 30, 2005
- Last update posted
- Apr 5, 2011
2003 – 2005
United States locations
- U.S. sites
- 32
- U.S. states
- 11
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Bay Pines VA Medical Center | Bay Pines | Florida | — | — |
| Pulmonary Associates of Brandon | Brandon | Florida | — | — |
| Jacksonville Cardiovascular Clinic | Jacksonville | Florida | — | — |
| Melbourne Internal Medicine Associates (MIMA) | Melbourne | Florida | — | — |
| Melbourne Internal Medical Associates (MIMA) | Palm Bay | Florida | — | — |
| Clinical Pharmacology Services | Tampa | Florida | — | — |
| Medical College of Georgia | Augusta | Georgia | — | — |
| Cardinal Bernardin Cancer Center | Maywood | Illinois | — | — |
| Loyola University Medical Center | Maywood | Illinois | — | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | — | — |
| Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office | Bloomfield Hills | Michigan | — | — |
| Henry Ford Hospital | Detroit | Michigan | — | — |
| St. Joseph Mercy - Oakland Clinical Research Office | Pontiac | Michigan | — | — |
| St. Joseph Mercy - Oakland | Pontiac | Michigan | — | — |
| William Beaumont Hospital / Clinical Research Center | Royal Oak | Michigan | — | — |
| William Beaumont Hospital Troy | Troy | Michigan | — | — |
| Lovelace Sandia Health Systems, Clinical Thrombosis Center | Albuquerque | New Mexico | — | — |
| University of New Mexico Hospital | Albuquerque | New Mexico | — | — |
| Lehigh Valley Hospital | Allentown | Pennsylvania | — | — |
| Crozer-Chester Medical Center | Upland | Pennsylvania | — | — |
| Lung & Chest Medical Associates | Spartanburg | South Carolina | — | — |
| Spartanburg Pharmaceutical Research | Spartanburg | South Carolina | — | — |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | — | — |
| The Methodist Hospital | Houston | Texas | — | — |
| Scott and White Memorial Hospital and Clinic | Temple | Texas | — | — |
| The University of Texas Health Center at Tyler | Tyler | Texas | — | — |
| Inova Alexandria Hospital | Alexandria | Virginia | — | — |
| Pulmonary Associates of Fredericksburg, Inc. | Fredericksburg | Virginia | — | — |
| McGuire VA Medical Center | Richmond | Virginia | — | — |
| Swedish Medical Center | Seattle | Washington | — | — |
| Pulmonary Specialists/Spokane Respiratory Consultants | Spokane | Washington | — | — |
| Sacred Heart Medical Center | Spokane | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00071279, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 5, 2011 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00071279 live on ClinicalTrials.gov.