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NCT00441727 · ClinicalTrials.gov registry record · Phase 3

Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
2,426
Enrollment target

NCT00441727: Completed Phase 3 study, sponsored by AstraZeneca.

NCT00441727 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 2,426 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (214% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00441727, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
2,426 participants
Enrollment target

Study Summary

The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

Primary Outcome

The occurrence of ulcer (mucosal break measuring \>= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Interventions

  • DRUG Placebo
  • DRUG Esomeprazole 40 mg
  • DRUG Esomeprazole 20 mg

Trial Details

FieldValue
Enrollment Target 2,426 participants
Start Date 2007-02
Est. Completion 2008-08
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT00441727 record still lists

NCT00441727 is an interventional study that assigns participants to a tested intervention. Its 2,426 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 (214% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00441727 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00441727 about?

NCT00441727 is a clinical study titled "Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)". The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

What is the current status of trial NCT00441727?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,426 participants. The study started on 2007-02. Estimated completion is 2008-08.

What interventions are being tested in trial NCT00441727?

The interventions under investigation include: Placebo (DRUG), Esomeprazole 40 mg (DRUG), Esomeprazole 20 mg (DRUG).

Who is sponsoring clinical trial NCT00441727?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00441727's enrollment target sits among peer trials

2,426 89th of 2000 higher than 1,912 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 NCT00441727, the US trial registry maintained by the National Library of Medicine. NCT00441727 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.