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GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

NCT00261352 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2009-04-22

No results posted yet for this study

Summary

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)

Conditions

Interventions

DRUG

Tesaglitazar

DRUG

Metformin

DRUG

Fenofibrate

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Galida Medical Science DIrector, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Completion
2006-12-31

Countries

  • Brazil
  • Canada
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Indonesia
  • Malaysia
  • Norway
  • Philippines
  • Portugal
  • Russia
  • Singapore
  • South Africa
  • Switzerland
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00261352 on ClinicalTrials.gov