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NCT00077753 · ClinicalTrials.gov registry record · Phase 4
EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization
A Phase 4 study of Venous Thromboembolism, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 4,726
- Enrollment target
- 20
- Study locations
NCT00077753: Completed Phase 4 study of Venous Thromboembolism, sponsored by Sanofi.
NCT00077753 is a Phase 4 study of Venous Thromboembolism that has completed, run by Sanofi. The registered enrollment target is 4,726 participants, below the 6,195-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00077753, a Phase 4 study of Venous Thromboembolism, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4,726 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary objective: * To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd Secondary objectives: * To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis * To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study * To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes: * Major and minor hemorrhage * Heparin induced thrombocytopenia * Serious adverse events * To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.
Conditions Studied
Interventions
- DRUG enoxaparin sodium
Study Locations (20)
Other
- Sanofi-Aventis - Buenos Aires
- Sanofi-Aventis - North Ryde
- Sanofi-Aventis - Vienna
- Sanofi-Aventis - Brussels
- Sanofi-Aventis - São Paulo
- Sanofi-Aventis - Laval
- Sanofi-Aventis - Bogotá
- Sanofi-Aventis - Paris
- Sanofi-Aventis - Berlin
- Sanofi-Aventis - Mumbai
- Sanofi-Aventis - Netanya
- Sanofi-Aventis - Milan
- Sanofi-Aventis - México
- Sanofi-Aventis - Warsaw
- Sanofi-Aventis - Moscow
- Sanofi-Aventis - Johannesburg
- Sanofi-Aventis - Barcelona
- Sanofi-Aventis - Mégrine
- Sanofi-Aventis - Guildford
New Jersey
- Sanofi-Aventis - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,726 participants |
| Start Date | 2002-02 |
| Est. Completion | 2007-02 |
| Phase | Phase 4 |
What the finished NCT00077753 record still lists
NCT00077753 is an interventional study that assigns participants to a tested intervention. Its 4,726 participants enrollment target places it among the larger protocols in the corpus, below the 6,195-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Venous Thromboembolism appearing as the primary indexed condition, and to 1 intervention - of which enoxaparin sodium is the first listed.
NCT00077753 names 20 study sites across 2 states, led by Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00077753 about?
NCT00077753 is a clinical study titled "EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization". Primary objective: * To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd Secondary objectives: * To assess the reduction in mortality rate at the end ...
What is the current status of trial NCT00077753?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4,726 participants. The study started on 2002-02. Estimated completion is 2007-02.
What conditions does trial NCT00077753 study?
This clinical trial studies the following conditions: Venous Thromboembolism.
What interventions are being tested in trial NCT00077753?
The interventions under investigation include: enoxaparin sodium (DRUG).
Who is sponsoring clinical trial NCT00077753?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00077753 being conducted?
This trial has 20 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00077753's enrollment target sits among peer trials
4,726 12th of 47 higher than 36 of 47 other Venous Thromboembolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Thromboembolism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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