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Clinical Trial Details

Trial ID: L3342
Source ID: NCT00261417
Associated Drug: Tesaglitazar
Title: Dose Response Study in Japanese Patients
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Tesaglitazar
Outcome Measures: Primary: Dose-response relationship of tesaglitazar in subjects with type 2 diabetes by the assessment of the effects of each of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) to placebo with respect to fasting plasma glucose | Secondary: Changes in the following variables from baseline to the end of the randomized treatment period:|Triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, total cholesterol apolipoproteins (Apo) (Apo A-I, Apo B and Apo CIII), and f|Glucose and insulin values during an oral glucose tolerance test|Effects on the reduction of insulin and glycosylated hemoglobin A1c levels|Effects on the proportion of fasting plasma glucose responders|Effects on the proportion of high-density lipoprotein cholesterol responders|Effects on the changes from baseline in weight and waist/hip ratio|Evaluate the pharmacokinetics of tesaglitazar|Assess the safety and tolerability of tesaglitazar compared to placebo
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 250
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2004-05
Completion Date: 2005-10
Results First Posted:
Last Update Posted: 2009-04-22
Locations: Research Site, Ashino, Japan|Research Site, Fuchu Keijinkai, Japan|Research Site, Fujimino, Japan|Research Site, Hijirino Koike, Japan|Research Site, Houseikai, Japan|Research Site, Hyuga, Japan|Research Site, Iriuchijima, Japan|Research Site, Iwase, Japan|Research Site, Kato, Japan|Research Site, Kawamata, Japan|Research Site, Keishukai Shirakawa, Japan|Research Site, Koga, Japan|Research Site, Kouhoku, Japan|Research Site, Kousei, Japan|Research Site, Kurosawa, Japan|Research Site, Nihonmatu, Japan|Research Site, Oki, Japan|Research Site, Saiseikai Fukuoka, Japan|Research Site, Sapporo, Japan|Research Site, Takamori, Japan
URL: https://clinicaltrials.gov/show/NCT00261417