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NCT00381238 · ClinicalTrials.gov registry record · Phase 2

Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
33
Enrollment target

NCT00381238: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT00381238 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00381238, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
33 participants
Enrollment target

Study Summary

This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease.

Primary Outcome

An AE was defined as any untoward medical occurrence or clinical investigation in a participant, temporally associated with the use of a medicinal product, whether or not, considered related to the medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. The number of participants with all AEs, drug related AEs, serious adverse events (SAEs), AE leading to permanent (prm) discontinuation (disc) of study

Interventions

  • DRUG rosiglitazone

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2006-06-20
Est. Completion 2009-02-03
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT00381238 record still lists

NCT00381238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).

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

NCT00381238 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00381238 about?

NCT00381238 is a clinical study titled "Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease". This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease.

What is the current status of trial NCT00381238?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2006-06-20. Estimated completion is 2009-02-03.

What interventions are being tested in trial NCT00381238?

The interventions under investigation include: rosiglitazone (DRUG).

Who is sponsoring clinical trial NCT00381238?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00381238's enrollment target sits among peer trials

33 1553rd of 2000 higher than 438 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00381238, the US trial registry maintained by the National Library of Medicine. NCT00381238 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.