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NCT00995410 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers

A Phase 3 study, sponsored by POZEN.

Completed
Registry status
Phase 3
Development phase
380
Enrollment target

NCT00995410: Completed Phase 3 study, sponsored by POZEN.

NCT00995410 is a Phase 3 study that has completed, run by POZEN. The registered enrollment target is 380 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00995410, a Phase 3 study, has completed, sponsored by POZEN.

COMPLETED
Registry status
Phase 3
Development phase
380 participants
Enrollment target

Study Summary

This study uses an open-label design and will be conducted in approximately 40 sites in the United States. Approximately 400 subjects will be enrolled in the study to ensure that approximately 300 subjects will have 6 months exposure to PA32540 and at least 100 subjects will have 12 months exposure to PA32540.

Primary Outcome

Incidence of adverse events and monitoring vital signs and clinical laboratory values. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC).

Interventions

  • DRUG PA32540

Trial Details

FieldValue
Enrollment Target 380 participants
Start Date 2009-10
Est. Completion 2011-05
Phase Phase 3
POZEN

24 total trials

What the finished NCT00995410 record still lists

NCT00995410 is an interventional study that assigns participants to a tested intervention. The registered 380 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 (51% lower).

The record links to 0 conditions, and to 1 intervention - of which PA32540 is the first listed.

NCT00995410 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00995410 about?

NCT00995410 is a clinical study titled "Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers". This study uses an open-label design and will be conducted in approximately 40 sites in the United States. Approximately 400 subjects will be enrolled in the study to ensure that approximately 300 subjects will have 6 months exposure to PA32540 and at least 100 subjects will have 12 months exposure ...

What is the current status of trial NCT00995410?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2009-10. Estimated completion is 2011-05.

What interventions are being tested in trial NCT00995410?

The interventions under investigation include: PA32540 (DRUG).

Who is sponsoring clinical trial NCT00995410?

This trial is sponsored by POZEN, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00995410's enrollment target sits among peer trials

380 983rd of 2000 higher than 1,014 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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Source: ClinicalTrials.gov NCT00995410, the US trial registry maintained by the National Library of Medicine. NCT00995410 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.