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NCT00790933 · ClinicalTrials.gov registry record · Phase 3
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,243
- Enrollment target
NCT00790933: Completed Phase 3 study, sponsored by Takeda.
NCT00790933 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 2,243 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (191% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00790933, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,243 participants
- Enrollment target
Study Summary
The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined
Interventions
- DRUG Vedolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,243 participants |
| Start Date | 2009-05-22 |
| Est. Completion | 2017-10-31 |
| Phase | Phase 3 |
What the finished NCT00790933 record still lists
NCT00790933 is an interventional study that assigns participants to a tested intervention. Its 2,243 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (191% higher).
The record links to 0 conditions, and to 1 intervention - of which Vedolizumab is the first listed.
NCT00790933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00790933 about?
NCT00790933 is a clinical study titled "An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease". The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
What is the current status of trial NCT00790933?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,243 participants. The study started on 2009-05-22. Estimated completion is 2017-10-31.
What interventions are being tested in trial NCT00790933?
The interventions under investigation include: Vedolizumab (DRUG).
Who is sponsoring clinical trial NCT00790933?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00790933's enrollment target sits among peer trials
2,243 95th of 2000 higher than 1,906 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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