GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes
NCT ID: NCT00300105
Last Updated: 2008-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
400 participants
INTERVENTIONAL
2005-10-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Tesaglitazar
Eligibility Criteria
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Inclusion Criteria
* Men or women who are \>=18 years of age
* Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
* Completed the last two visits of randomized treatment period in GALLANT 4
Exclusion Criteria
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
* Creatinine levels above twice the normal range
* Creatine kinase above 3 times the upper limit of normal
* Previous enrollment in this long-term extension study
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Galida Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Hasselt, , Belgium
Research Site
Liège, , Belgium
Research Site
Sint-Gillis-Waas, , Belgium
Research Site
Steenokkerzeel, , Belgium
Research Site
Shatin, , Hong Kong
Research Site
Balatonfüred, , Hungary
Research Site
Budapest, , Hungary
Research Site
Kaposvár, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Székesfehérvár, , Hungary
Research Site
Gubbio, , Italy
Research Site
Milan, , Italy
Research Site
Perugia, , Italy
Research Site
Piacenza, , Italy
Research Site
Reggio Emilia, , Italy
Research Site
Udine, , Italy
Research Site
Kubang Kerian, Kelantan, Malaysia
Research Site
Kuala Lumpur, , Malaysia
Research Site
Makati City, , Philippines
Research Site
Manila, , Philippines
Research Site
Pasig, , Philippines
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Płock, , Poland
Research Site
Torun, , Poland
Research Site
Tychy, , Poland
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Warsaw, , Poland
Research Site
£ód?, , Poland
Research Site
Banská Bystrica, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Ilava, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Kysucké Nové Mesto, , Slovakia
Research Site
Lučenec, , Slovakia
Research Site
Ľubochňa, , Slovakia
Research Site
Nitra, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Trnava, , Slovakia
Research Site
Johannesburg, Gauteng, South Africa
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Bangkok, , Thailand
Countries
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Other Identifiers
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EudraCT No 2004-005243-97
Identifier Type: -
Identifier Source: secondary_id
D6160C00047
Identifier Type: -
Identifier Source: org_study_id
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