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NCT01500135 · ClinicalTrials.gov registry record · Phase 3
Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT01500135 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 150 participants.
The verdict
NCT01500135, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
Present trial is the third study that in combination with two completed studies (one being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and efficacy data to support extending the current label of TachoSil® to a general hemostasis indication across several surgical procedures and organ systems in the USA.
Interventions
- DRUG TachoSil®
- DRUG Surgicel® Original
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01500135
The ClinicalTrials.gov registry entry for NCT01500135 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TachoSil® is the first listed.
NCT01500135 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01500135 about?
NCT01500135 is a clinical study titled "Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery". Present trial is the third study that in combination with two completed studies (one being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and efficacy data to support extending the current label of TachoSil® to a genera...
What is the current status of trial NCT01500135?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2012-03. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01500135?
The interventions under investigation include: TachoSil® (DRUG), Surgicel® Original (DRUG).
Who is sponsoring clinical trial NCT01500135?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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