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NCT00345618 · ClinicalTrials.gov registry record · Phase 3
Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,202
- Enrollment target
NCT00345618 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 3,202 participants.
The verdict
NCT00345618, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,202 participants
- Enrollment target
Study Summary
Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.
Interventions
- DRUG Warfarin
- DRUG Idrabiotaparinux sodium
- DRUG Avidin
- DRUG Placebo (for idrabiotaparinux sodium)
- DRUG Placebo (for warfarin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,202 participants |
| Start Date | 2006-06 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00345618
The ClinicalTrials.gov registry entry for NCT00345618 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Warfarin is the first listed.
NCT00345618 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00345618 about?
NCT00345618 is a clinical study titled "Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach". Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) ...
What is the current status of trial NCT00345618?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,202 participants. The study started on 2006-06. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00345618?
The interventions under investigation include: Warfarin (DRUG), Idrabiotaparinux sodium (DRUG), Avidin (DRUG), Placebo (for idrabiotaparinux sodium) (DRUG), Placebo (for warfarin) (DRUG).
Who is sponsoring clinical trial NCT00345618?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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