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NCT00527904 · ClinicalTrials.gov registry record · Phase 3
A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)
A Phase 3 study, sponsored by POZEN.
- Completed
- Registry status
- Phase 3
- Development phase
- 239
- Enrollment target
NCT00527904: Completed Phase 3 study, sponsored by POZEN.
NCT00527904 is a Phase 3 study that has completed, run by POZEN. The registered enrollment target is 239 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00527904, a Phase 3 study, has completed, sponsored by POZEN.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 239 participants
- Enrollment target
Study Summary
This study uses an open-label design and will be conducted in approximately 60 sites aiming to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12 months exposure to PN400 (VIMOVO).
Primary Outcome
Incidence of adverse events and monitoring vital signs, clinical laboratory values, physical exams, ECG. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. Treatment-emergent AEs were also summarized by maximum severity, by quartile of number of doses
Interventions
- DRUG PN 400 (VIMOVO)
- DRUG PN400 (VIMOVO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00527904 record still lists
NCT00527904 is an interventional study that assigns participants to a tested intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which PN 400 (VIMOVO) is the first listed.
NCT00527904 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00527904 about?
NCT00527904 is a clinical study titled "A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 (VIMOVO)". This study uses an open-label design and will be conducted in approximately 60 sites aiming to enroll a total number of 200 subjects to ensure that at least 100 subjects will have 12 months exposure to PN400 (VIMOVO).
What is the current status of trial NCT00527904?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 239 participants. The study started on 2007-03. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00527904?
The interventions under investigation include: PN 400 (VIMOVO) (DRUG), PN400 (VIMOVO) (DRUG).
Who is sponsoring clinical trial NCT00527904?
This trial is sponsored by POZEN, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00527904's enrollment target sits among peer trials
239 1291st of 2000 higher than 710 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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