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NCT00550420 · ClinicalTrials.gov registry record · Phase 3
Study Of Rosiglitazone XR In Subjects With Mild-to-Moderate Alzheimers
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 331
- Enrollment target
NCT00550420: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT00550420 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 331 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00550420, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 331 participants
- Enrollment target
Study Summary
This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed AVA105640. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed AVA105640. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status
Primary Outcome
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The drug related-AEs of special interest (AESI) was reported. The severity of the AESI was categorized as mild, moderate and severe. Number of participants with AEs were reported for treatment duration of the study.
Interventions
- DRUG Rosiglitazone XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2007-10-01 |
| Est. Completion | 2009-02-12 |
| Phase | Phase 3 |
Why NCT00550420 stopped before completion
NCT00550420 is an interventional study that assigns participants to a tested intervention. The registered 331 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 (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Rosiglitazone XR is the first listed.
NCT00550420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00550420 about?
NCT00550420 is a clinical study titled "Study Of Rosiglitazone XR In Subjects With Mild-to-Moderate Alzheimers". This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed AVA105640. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study f...
What is the current status of trial NCT00550420?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 331 participants. The study started on 2007-10-01. Estimated completion is 2009-02-12.
What interventions are being tested in trial NCT00550420?
The interventions under investigation include: Rosiglitazone XR (DRUG).
Who is sponsoring clinical trial NCT00550420?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00550420's enrollment target sits among peer trials
331 1066th of 2000 higher than 935 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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