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Clinical Trial Details

Trial ID: L5706
Source ID: NCT00261352
Associated Drug: Tesaglitazar
Title: GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Tesaglitazar|DRUG: Metformin|DRUG: Fenofibrate
Outcome Measures: Primary: The change in HDL-C from baseline to the end of the randomized treatment period. | Secondary: Changes in the following variables from baseline to the end of the randomized treatment period:|Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)|Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values|The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C|Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)|Central obesity (waist/hip ratio)|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: 1000
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: 2009-04-22
Locations: Research Site, Fortaleza, CE, Brazil|Research Site, Goiânia, GO, Brazil|Research Site, Porto Alegre, RS, Brazil|Research Site, Curitiba, Brazil|Research Site, Sao Paulo, 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|Research Site, Bolton, Ontario, Canada|Research Site, Brampton, Ontario, Canada|Research Site, Etobicoke, Ontario, Canada|Research Site, Hastings, Ontario, Canada|Research Site, Kingston, Ontario, Canada|Research Site, Kitchener, Ontario, Canada|Research Site, London, Ontario, Canada|Research Site, Mississauga, Ontario, Canada|Research Site, Napanee, Ontario, Canada|Research Site, Newboro, Ontario, Canada|Research Site, Ottawa, Ontario, Canada|Research Site, Montreal, Quebec, Canada|Research Site, Pointe-Claire, Quebec, Canada|Research Site, Sherbrooke, Quebec, Canada|Research Site, Helsinki, Finland|Research Site, Kuopio, Finland|Research Site, Lahti, Finland|Research Site, Mikkeli, Finland|Research Site, Oulu, Finland|Research Site, Porvoo, Finland|Research Site, Savonlinna, Finland|Research Site, Seinäjoki, Finland|Research Site, Suonenjoki, Finland|Research Site, Tampere, Finland|Research Site, Turku, Finland|Research Site, Vaasa, Finland|Research Site, Aix En Provence, France|Research Site, Ambriere Les Vallees, France|Research Site, Beziers, France|Research Site, Briey Cedex, France|Research Site, Broglie, France|Research Site, Chateau Gontier, France|Research Site, Cremeaux, France|Research Site, Falaise, France|Research Site, Fontaine Saint Martin, France|Research Site, Freyming Merlebach, France|Research Site, GAN, France|Research Site, Hyeres, France|Research Site, Jarny, France|Research Site, Jort, France|Research Site, L'aigle, France|Research Site, Lambersart, France|Research Site, Le Lavandou, France|Research Site, Lille, France|Research Site, Lomme Cedex, France|Research Site, Marange Silvange, France|Research Site, Marignane, France|Research Site, Mars La Tour, France|Research Site, Martigues, France|Research Site, Mayenne, France|Research Site, Metz, France|Research Site, Mondelange, France|Research Site, Montbrison, France|Research Site, Montpellier, France|Research Site, Moutiers, France|Research Site, Nantes Cedex 01, France|Research Site, Nantes Cedex 1, France|Research Site, Paris, France|Research Site, Poitiers, France|Research Site, Roanne, France|Research Site, Roquevaire, France|Research Site, Rugles, France|Research Site, Saint Chamond, France|Research Site, Saint Jean de Luz, France|Research Site, Tantonville, France|Research Site, Heidelberg, Baden-Württemberg, Germany|Research Site, Stuttgart, Baden-Württemberg, Germany|Research Site, München, Bayern, Germany|Research Site, Frankfurt, Hessen, Germany|Research Site, Hannover, Niedersachsen, Germany|Research Site, Düsseldorf, Nordrhein-Westfalen, Germany|Research Site, Münster, Nordrhein-Westfalen, Germany|Research Site, Dresden, Sachsen, Germany|Research Site, Aschaffenburg, Germany|Research Site, Beckum, Germany|Research Site, Berlin, Germany|Research Site, Dresden, Germany|Research Site, Düsseldorf, Germany|Research Site, Essen, Germany|Research Site, Gelnhausen, Germany|Research Site, Hannover, Germany|Research Site, Heidelberg, Germany|Research Site, Heilbronn, Germany|Research Site, Künzing, Germany|Research Site, Nürnberg, Germany|Research Site, Pirna, Germany|Research Site, Hong Kong, Hong Kong|Research Site, Shatin, Hong Kong|Research Site, Balatonfüred, Hungary|Research Site, Budapest, Hungary|Research Site, Gy¿r, Hungary|Research Site, Kaposvár, Hungary|Research Site, Kecskemét, Hungary|Research Site, Miskolc, Hungary|Research Site, Siófok, Hungary|Research Site, Székesfehérvár, Hungary|Research Site, Mumbai, Mashatra, India|Research Site, Bangalore, India|Research Site, Delhi, India|Research Site, India, India|Research Site, Jakarta, DKI Jakarta, Indonesia|Research Site, Malang, East Java, Indonesia|Research Site, Kuala Lumpur, Malaysia|Research Site, Penang, Malaysia|Research Site, Petaling Jaya, Malaysia|Research Site, Bergen, Norway|Research Site, Bodø, Norway|Research Site, Elverum, Norway|Research Site, Fredrikstad, Norway|Research Site, Hamar, Norway|Research Site, Oslo, Norway|Research Site, Paradis, Norway|Research Site, Trondheim, Norway|Research Site, Tvedestrand, Norway|Research Site, Cebu City, Philippines|Research Site, Makati City, Philippines|Research Site, Manila, Philippines|Research Site, Almada, Portugal|Research Site, Amadora, Portugal|Research Site, Caldas da Rainha, Portugal|Research Site, Elvas, Portugal|Research Site, Lisboa, Portugal|Research Site, Portalegre, Portugal|Research Site, Moscow, Russian Federation|Research Site, St.Petersburg, Russian Federation|Research Site, Yaroslavl, Russian Federation|Research Site, Singapore, Singapore|Research Site, Cape Town, South Africa|Research Site, Durban, South Africa|Research Site, Johannesburg, South Africa|Research Site, Pretoria, South Africa|Research Site, Bern, Switzerland|Research Site, Chur, Switzerland|Research Site, Ilanz, Switzerland|Research Site, Lausanne, Switzerland|Research Site, Monthey, Switzerland|Research Site, Sion, Switzerland|Research Site, Zürich, Switzerland|Research Site, Yong-Kang City, Tainan County, Taiwan|Research Site, Changhua, Taiwan|Research Site, Taichung, Taiwan|Research Site, Taipei, Taiwan
URL: https://clinicaltrials.gov/show/NCT00261352

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details
D311 Fenofibrate small molecule DB01039 Details