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A Double-blind, Multi-centre, Active-Controlled (15, 30, and 45mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar (0.5 and 1 mg) in Patients with T...

Mise à jour : Il y a 5 ans
Référence : EUCTR2004-003840-22

A Double-blind, Multi-centre, Active-Controlled (15, 30, and 45mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar (0.5 and 1 mg) in Patients with Type 2 Diabetes Mellitus

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Extrait

The primary objective is to monitor the long-term safety and tolerability of tesaglitazar (0.5 and 1 mg) versus pioglitazone (15, 30 and 45 mg), with or without other oral anti-diabetic drugs, when administered up to 104weeks in an extension study from the GALLANT 6 study in patients with type 2 diabetes by evaluation of adverse events (AEs), laboratory variables, physical examination, cardiac evaluation, hypoglycaemic events, electrocardiogram (ECG), vital signs (blood pressure (BP) and pulse) and body weight.

Critère d'inclusion

  • type II diabetes mellitus

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