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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 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 1,461 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00490568
The ClinicalTrials.gov registry entry for NCT00490568 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,461 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.
NCT00490568 reports 0 study locations.
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.
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