CKDkb: a knowledge base and platform for drug development against non-alcoholic fatty liver disease

Clinical Trial Details

Trial ID:	L2025
Source ID:	NCT00214591
Associated Drug:	Galida
Title:	GALLANT 5 Tesaglitazar Versus Metformin
Acronym:
Status:	TERMINATED
Study Results:	NO
Results:
Conditions:	Diabetes Mellitus, Type 2
Interventions:	DRUG: GALIDA
Outcome Measures:	Primary: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) \| Secondary: The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide\|Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model\|Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and co\|C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio\|FPG, homeostasis assessment model, insulin, proinsulin, C-peptide\|Tumor necrosis factor-alpha, intracellular adhesion molecule-1\|Fibrinogen\|Urinary albumin excretion\|Waist/hip ratio\|Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values\|Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C\|Pharmacokinetics of tesaglitazar\|Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination
Sponsor/Collaborators:	Sponsor: AstraZeneca
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	580
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE\|Primary Purpose: TREATMENT
Start Date:	2004-08
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, Carlisle, Arizona, United States\|Research Center, Sherwood, Arizona, United States\|Research Site, Chula Vista, California, United States\|Research Site, Escondido, California, United States\|Research Site, Huntington Beach, California, United States\|Research Site, Los Angeles, California, United States\|Research Site, Mission Viejo, California, United States\|Research Site, Orange, California, United States\|Research Site, Pasadena, California, United States\|Research Site, Pomona, California, United States\|Research Site, Redondo Beach, California, United States\|Research Site, Sacramento, California, United States\|Research Site, Colorado Springs, Colorado, United States\|Research Site, Wheat Ridge, Colorado, United States\|Research Site, Clearwater, Florida, United States\|Research Site, Gainesville, Florida, United States\|Research Site, Hollywood, Florida, United States\|Research Site, Jacksonville, Florida, United States\|Research Site, Miami, Florida, United States\|Research Site, West Palm Beach, Florida, United States\|Research Site, Atlanta, Georgia, United States\|Research Site, Brunswick, Georgia, United States\|Research Site, Carollton, Georgia, United States\|Research Site, Honolulu, Hawaii, United States\|Research Site, Boise, Idaho, United States\|Research Site, Evansville, Indiana, United States\|Research Site, Kansas City, Kansas, United States\|Research Site, Overland Park, Kansas, United States\|Research Site, Witchita, Kansas, United States\|Research Site, Bossier City, Louisiana, United States\|Research Site, New Orleans, Louisiana, United States\|Research Site, Baltimore, Maryland, United States\|Research Site, Kalamazoo, Missouri, United States\|Research Site, Las Vegas, Nevada, United States\|Research Site, Hamilton, New Jersey, United States\|Research Site, Albuquerque, New Mexico, United States\|Research Site, Albany, New York, United States\|Research Site, Bronx, New York, United States\|Research Site, New York, New York, United States\|Research Site, Pahrump, New York, United States\|Research Site, Rochester, New York, United States\|Research Site, White Plains, New York, United States\|Research Site, Charlotte, North Carolina, United States\|Research Site, Cincinnati, Ohio, United States\|Research Site, Dayton, Ohio, United States\|Research Site, Kettering, Ohio, United States\|Research Site, Oklahoma City, Oklahoma, United States\|Research Site, Medford, Oregon, United States\|Research Site, Philadelphia, Pennsylvania, United States\|Research Site, Simpsonville, South Carolina, United States\|Research Site, Morristown, Tennessee, United States\|Research Site, Corpus Christi, Texas, United States\|Research Site, Dallas, Texas, United States\|Research Site, Lubbock, Texas, United States\|Research Site, San Antonio, Texas, United States\|Research Site, Burke, Virginia, United States\|Research Site, Norfolk, Virginia, United States\|Research Site, Richmond, Virginia, United States\|Research Site, Tacoma, Washington, United States\|Research Site, Menomonee Falls, Wisconsin, United States\|Research Site, Milwaukee, Wisconsin, United States\|Research Site, Helsinki, Finland\|Research Site, Hämeenlinna, Finland\|Research Site, Joensuu, Finland\|Research Site, Kouvola, Finland\|Research Site, Kuopio, Finland\|Research Site, Mikkeli, Finland\|Research Site, Oulu, Finland\|Research Site, Salo, Finland\|Research Site, Tampere, Finland\|Research Site, Vantaa, Finland\|Research Site, Aschaffenburg, Germany\|Research Site, Bad Segeberg, Germany\|Research Site, Beckum, Germany\|Research Site, Berlin, Germany\|Research Site, Dresden, Germany\|Research Site, Ehrenberg, Germany\|Research Site, Essen, Germany\|Research Site, Feldafing, Germany\|Research Site, Hamburg, Germany\|Research Site, Hannover, Germany\|Research Site, Hermaringen, Germany\|Research Site, Künzing, Germany\|Research Site, Langen, Germany\|Research Site, Mannheim, Germany\|Research Site, Marl, Germany\|Research Site, Nürnberg, Germany\|Research Site, Pirna, Germany\|Research Site, Rotenburg/Fulda, Germany\|Research Site, Ashkelon, Israel\|Research Site, Haifa, Israel\|Research Site, Holon, Israel\|Research Site, Jerusalem, Israel\|Research Site, Rishon-Lezion, Israel\|Research Site, Tel Aviv, Israel\|Research Site, Zefat, Israel\|Research Site, Beek en Donk, Netherlands\|Research Site, Bennebroe, Netherlands\|Research Site, Den Haag, Netherlands\|Research Site, Deurne, Netherlands\|Research Site, Huizen, Netherlands\|Research Site, Losser, Netherlands\|Research Site, Nijverdal, Netherlands\|Research Site, Rijswijk, Netherlands\|Research Site, Roelofarendsveen, Netherlands\|Research Site, Rotterdam, Netherlands\|Research Site, Bergen, Norway\|Research Site, Oslo, Norway\|Research Site, Østerås, Norway\|Research Site, San Vicente de Raspeig, Alicante, Spain\|Research Site, Villar del Arzobispo, Valencia, Spain\|Research Site, Alzira (Valencia), Spain\|Research Site, Barcelona, Spain\|Research Site, Begonte (Lugo), Spain\|Research Site, Madrid, Spain\|Research Site, Sevilla, Spain\|Research Site, Aberdeen, United Kingdom\|Research Site, Ayr, United Kingdom\|Research Site, Bath, United Kingdom\|Research Site, Berks, United Kingdom\|Research Site, Bucks, United Kingdom\|Research Site, Coventry, United Kingdom\|Research Site, Dundee, United Kingdom\|Research Site, Glasgow, United Kingdom\|Research Site, Manchester, United Kingdom\|Research Sites, Northampton, United Kingdom\|Research Site, Wiltshire, United Kingdom
URL:	https://clinicaltrials.gov/show/NCT00214591

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Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress

Clinical Trial Details

Summary

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Associated Data

Associated NAFLD Drugs (0)