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Clinical Trial Details

Trial ID: L2364
Source ID: NCT00226330
Associated Drug: Tesaglitazar
Title: GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Tesaglitazar|DRUG: Pioglitazone
Outcome Measures: Primary: Adverse events|Laboratory variables|Physical examination|Cardiac evaluation|Hypoglycemic events|Electrocardiogram|Vital signs (blood pressure and pulse)|Body weight | Secondary: Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c|Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)|Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C|C-reactive protein (CRP)|Central obesity (waist circumference, hip circumference, waist/hip ratio)|Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1100
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2005-03
Completion Date: 2006-12
Results First Posted:
Last Update Posted: 2010-11-19
Locations: Research Site, Birmingham, Alabama, United States|Research Site, Columbiana, Alabama, United States|Research Site, Mobile, Alabama, United States|Research Site, Chandler, Arizona, United States|Research Site, Mesa, Arizona, United States|Research Site, Phoenix, Arizona, United States|Research Site, Sierra Vista, Arizona, United States|Research Site, Tucson, Arizona, United States|Research Site, Jonesboro, Arkansas, United States|Research Site, Little Rock, Arkansas, United States|Research Site, Searcy, Arkansas, United States|Research Site, Anaheim, California, United States|Research Site, Carmichael, California, United States|Research Site, Dinuba, California, United States|Research Site, Elk Grove, California, United States|Research Site, Encinitas, California, United States|Research Site, Encino, California, United States|Research Site, Fresno, California, United States|Research Site, Greenbrae, California, United States|Research Site, Loma Linda, California, United States|Research Site, Long Beach, California, United States|Research Site, Los Angeles, California, United States|Research Site, Mission Viejo, California, United States|Research Site, Northridge, California, United States|Research Site, Pasadena, California, United States|Research Site, Redondo Beach, California, United States|Research Site, Riverside, California, United States|Research Site, Sacramento, California, United States|Research Site, Santa Ana, California, United States|Research Site, Santa Monica, California, United States|Research Site, Spring Valley, California, United States|Research Site, Tustin, California, United States|Research Site, Walnut Creek, California, United States|Research Site, West Hills, California, United States|Research Site, Newark, Delaware, United States|Research Site, Washington, District of Columbia, United States|Research Site, Brandon, Florida, United States|Research Site, Cooper City, Florida, United States|Research Site, Delray Beach, Florida, United States|Research Site, Gainesville, Florida, United States|Research Site, Hialeah, Florida, United States|Research Site, Hollywood, Florida, United States|Research Site, Jacksonville, Florida, United States|Research Site, Melbourne, Florida, United States|Research Site, Miami, Florida, United States|Research Site, Ocoee, Florida, United States|Research Site, Orlando, Florida, United States|Research Site, Plantation, Florida, United States|Research Site, W. Palm Beach, Florida, United States|Research Site, Atlanta, Georgia, United States|Research Site, Augusta, Georgia, United States|Research Site, Columbus, Georgia, United States|Research Site, Dunwoody, Georgia, United States|Research Site, Berwyn, Illinois, United States|Research Site, Chicago, Illinois, United States|Research Site, Elk Grove Village, Illinois, United States|Research Site, Gurnee, Illinois, United States|Research Site, Melrose Park, Illinois, United States|Research Site, North Chicago, Illinois, United States|Research Site, Peoria, Illinois, United States|Research Site, Sterling, Illinois, United States|Research Site, Indianapolis, Indiana, United States|Research Site, Des Moines, Iowa, United States|Research Site, Waterloo, Iowa, United States|Research Site, Topeka, Kansas, United States|Research Site, Witchita, Kansas, United States|Research Site, Lexington, Kentucky, United States|Research Site, Louisville, Kentucky, United States|Research Site, New Orleans, Louisiana, United States|Research Site, Slidell, Louisiana, United States|Research Site, Baltimore, Maryland, United States|Research Site, Columbia, Maryland, United States|Research Site, Haverhill, Massachusetts, United States|Research Site, Petoskey, Michigan, United States|Research Site, Excelsior Springs, Missouri, United States|Research Site, Richmond Heights, Missouri, United States|Research Site, Rolla, Missouri, United States|Research Site, Las Vegas, Nevada, United States|Research Site, North Las Vegas, Nevada, United States|Research Site, Pahrump, Nevada, United States|Research Site, Reno, Nevada, United States|Research Site, Pleasantville, New Jersey, United States|Research Site, Manlius, New York, United States|Research Site, New York, New York, United States|Research Site, Olean, New York, United States|Research Site, Staten Island, New York, United States|Research Site, Asheville, North Carolina, United States|Research Site, Winston-Salem, North Carolina, United States|Research Site, Cincinnati, Ohio, United States|Research Site, Lakewood, Ohio, United States|Research Site, Oklahoma City, Oklahoma, United States|Research Site, Medford, Oregon, United States|Research Site, Portland, Oregon, United States|Research Site, Altoona, Pennsylvania, United States|Research Site, Erie, Pennsylvania, United States|Research Site, Philadelphia, Pennsylvania, United States|Research Site, Reading, Pennsylvania, United States|Research Site, Warminster, Pennsylvania, United States|Research Site, West Chester, Pennsylvania, United States|Research Site, Columbia, South Carolina, United States|Research Site, Memphis, Tennessee, United States|Research Site, Carrollton, Texas, United States|Research Site, Dallas, Texas, United States|Research Site, North Richland Hills, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Salt Lake City, Utah, United States|Research Site, Norfolk, Virginia, United States|Research Site, Virginia Beach, Virginia, United States|Research Site, Gig Harbor, Washington, United States|Research Site, Huntington, West Virginia, United States|Research Site, Moron, Buenos Aires, Argentina|Research Site, Quilmes, Buenos Aires, Argentina|Research Site, Ciudad de Buenos Aires, Argentina|Research Site, Córdoba - Córdoba, Argentina|Research Site, Rosario, Argentina|Research Site, Salta - Salta, Argentina|Research Site, Curitiba, Brazil|Research Site, Fortaleza, Brazil|Research Site, Goiânia, Brazil|Research Site, Porto Alegre, Brazil|Research Site, Ribeirão Preto, Brazil|Research Site, São Paulo, Brazil|Research Site, Edmonton, Alberta, Canada|Research Site, Abbotsford, British Columbia, Canada|Research Site, Chilliwack, British Columbia, Canada|Research Site, Vancouver, British Columbia, Canada|Research Site, Victoria, British Columbia, Canada|Research Site, St. John's, Newfoundland and Labrador, Canada|Research Site, Dartmouth, Nova Scotia, Canada|Research Site, Halifax, Nova Scotia, Canada|Research Site, Truro, Nova Scotia, Canada|Research Site, Windsor, Nova Scotia, Canada|Research Site, Brampton, Ontario, Canada|Research Site, Etobicoke, Ontario, Canada|Research Site, Kingston, Ontario, Canada|Research Site, Niagara Falls, Ontario, Canada|Research Site, Oshawa, Ontario, Canada|Research Site, Scarborough, Ontario, Canada|Research Site, St. Catharines, Ontario, Canada|Research Site, Toronto, Ontario, Canada|Research Site, Chicoutimi, Quebec, Canada|Research Site, Longueuil, Quebec, Canada|Research Site, Montreal, Quebec, Canada|Research Site, Trois-Rivières, Quebec, Canada|Research Site, Helsinki, Finland|Research Site, Kauniainen, Finland|Research Site, Kuopio, Finland|Research Site, Pietarsaari, Finland|Research Site, Pori, Finland|Research Site, Tampere, Finland|Research Site, Guadalajara, Jalisco., Mexico|Research Site, México, D.F., Mexico|Research Site, Nuevo León, Monterrey, Mexico|Research Site, Puebla, Mexico, Mexico|Research Site, Torreon, Mexico|Research Site, Zapopan, Mexico|Research Site, Belfast, United Kingdom|Research Site, Cardiff, United Kingdom|Research Site, Co Antrim N Ireland, United Kingdom|Research Site, Co. Wexford, Ireland, United Kingdom|Research Site, Dublin, United Kingdom|Research Site, Edinburgh, United Kingdom|Research Site, Glasgow, United Kingdom|Research Site, Kent, United Kingdom|Research Site, Leeds, United Kingdom|Research Site, Mid Glamorgan, United Kingdom|Research Site, Pembrokeshire, United Kingdom|Research Site, Plymouth, United Kingdom|Research Site, Reading, United Kingdom|Research Site, Surrey, United Kingdom|Research Site, Wiltshire, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00226330