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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00255645
Other study ID # D6160C00056
Secondary ID EudraCT No 2005-
Status Terminated
Phase Phase 3
First received November 18, 2005
Last updated March 14, 2008
Start date September 2005
Est. completion date December 2006

Study information

Verified date March 2008
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 4500
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Argentina Research Site Ciudad de Buenos Aires
Argentina Research Site Córdoba
Argentina Research Site Moron Buenos Aires
Argentina Research Site Quilmes Buenos Aires
Argentina Research Site Rosario
Argentina Research Site Salta
Australia Research Site Adelaide
Australia Research Site Brisbane
Australia Research Site Cairns
Australia Research Site Geelong
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Australia Research Site Perth
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Belgium Research Site Antwerpen
Belgium Research Site Braine-L'alleud
Belgium Research Site Hasselt
Belgium Research Site Liege
Belgium Research Site Merksem
Belgium Research Site Sint-Gillis-Waas
Belgium Research Site Steenokkerzeel
Brazil Research Site Curitiba
Brazil Research Site Fortaleza
Brazil Research Site Goiânia
Brazil Research Site Porto Alegre
Brazil Research Site Ribeirão Preto
Brazil Research Site São Paulo
Canada Research Site Abbotsford British Columbia
Canada Research Site Bay Roberts Newfoundland and Labrador
Canada Research Site Bolton Ontario
Canada Research Site Brampton Ontario
Canada Research Site Calgary Alberta
Canada Research Site Chicoutimi Quebec
Canada Research Site Coquitlam British Columbia
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Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Czech Republic,  Estonia,  Finland,  Former Serbia and Montenegro,  France,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Indonesia,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Norway,  Philippines,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

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