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A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined With Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin
This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
Fortaleza, Ceará, Brazil
Research Site
Goiânia, Goiás, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
Curitiba, Brazil
Research Site
Calgary, Alberta, Canada
Research Site
Surrey, British Columbia, Canada
Research Site
Bay Roberts, Newfoundland and Labrador, Canada
Research Site
Mount Pearl, Newfoundland and Labrador, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Start Date
March 1, 2005
Completion Date
December 1, 2006
Last Updated
April 22, 2009
1,000
Estimated participants
Tesaglitazar
DRUG
Metformin
DRUG
Fenofibrate
DRUG
Lead Sponsor
AstraZeneca
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06671587