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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 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 331 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00550420
The ClinicalTrials.gov registry entry for NCT00550420 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rosiglitazone XR is the first listed.
NCT00550420 reports 0 study locations.
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.
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