An Open-Label, Multi-Centre and Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 1 mg in Patients With Type 2 Diabetes Mellitus.

TerminadoFase 3ClinicalTrials.gov

ID: NCT00252876Tipo: INTERVENTIONALInicio: 1 de mar de 2005Fin estimado: 1 de ene de 2007

Traducción no disponible, mostrando original

Resumen

This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Provision of a written informed consent
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 2/22, 5, 7, 8 or 14 studies.

Criterios de exclusión

Type 1 diabetes
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

Intervenciones

drug

tesaglitazar

Ubicaciones

Research Site

Morón, Buenos Aires, Argentina

Research Site

Quilmes, Buenos Aires, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Rosario, Argentina

Research Site

Salta - Salta, Argentina

Patrocinadores

PrincipalAstraZeneca

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