This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseII/III studies GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and...
Date First Received: November 18, 2005
Last Updated: March 14, 2008
Verified by: AstraZeneca, March 2008
Clinical Trial Phase: Phase 3 | Start Date: September 2005
Overall Status: Terminated
Estimated Enrollment: 4500
Brief Summary
Official Title: “A Long-Term, Post-Treatment, Safety Follow-Up, Multi-Center Study in Patients With Type 2 Diabetes Mellitus From the GALLANT, GALLEX or ARMOR Studies.”
Condition Keyword(s):
This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseII/III studies GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and adverse event recording.
Study Type: Observational
Study Design: Prospective
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Provision of a written informed consent
- Men or women who either completed at least 6 months in a previous treatment study
- GALLANT, GALLEX or ARMOR or met a pre-defined laboratory or clinical finding during participation in any of the said studies.
Exclusion Criteria:
- Received open-label treatment with tesaglitazar (since this is a post-treatment study)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
AstrasZeneca Galida Medical Science Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00255645
Study ID Number: D6160C00056
ClinicalTrials.gov Identifier: NCT00255645
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
