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NCT00490568 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,461
- Enrollment target
NCT00490568: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT00490568 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 1,461 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00490568, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,461 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 either AVA102670 or AVA102672. 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 as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. 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 either AVA102670 or AVA102672. 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
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study.
Interventions
- DRUG Rosiglitazone XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,461 participants |
| Start Date | 2007-08-08 |
| Est. Completion | 2009-06-01 |
| Phase | Phase 3 |
Why NCT00490568 stopped before completion
NCT00490568 is an interventional study that assigns participants to a tested intervention. Its 1,461 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 (89% higher).
The record links to 0 conditions, and to 1 intervention - of which Rosiglitazone XR is the first listed.
NCT00490568 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00490568 about?
NCT00490568 is a clinical study titled "Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy 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 either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 ...
What is the current status of trial NCT00490568?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,461 participants. The study started on 2007-08-08. Estimated completion is 2009-06-01.
What interventions are being tested in trial NCT00490568?
The interventions under investigation include: Rosiglitazone XR (DRUG).
Who is sponsoring clinical trial NCT00490568?
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 NCT00490568's enrollment target sits among peer trials
1,461 164th of 2000 higher than 1,837 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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