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Clinical Trial Details

Trial ID: L3901
Source ID: NCT00362323
Associated Drug: Fenofibrate (F) + Metformin (M) Hydrochloride Fixed Combination
Title: Fenofibrate and Metformin Fixed Combination vs Metformin - FAME METFO
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Dyslipidemia/Glucose Metabolism Disorder
Interventions: DRUG: fenofibrate (F) + metformin (M) hydrochloride fixed combination|DRUG: Metformin
Outcome Measures: Primary: TG / HDL-C ratio, 24 weeks | Secondary: Lipid and glycemic parameters, 24 weeks
Sponsor/Collaborators: Sponsor: Solvay Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 482
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-10
Completion Date: 2009-03
Results First Posted:
Last Update Posted: 2010-04-16
Locations: C LF23-0121 06 01 Site107, Brno, Czech Republic|C LF23-0121 06 01 Site108, Holesov, Czech Republic|C LF23-0121 06 01 Site101, Karlovy Vary, Czech Republic|C LF23-0121 06 01 Site106, Olomouc, Czech Republic|C LF23-0121 06 01 Site109, Olomouc, Czech Republic|C LF23-0121 06 01 Site103, Pardubice, Czech Republic|C LF23-0121 06 01 Site102, Praha, Czech Republic|C LF23-0121 06 01 Site104, Praha, Czech Republic|C LF23-0121 06 01 Site105, Praha, Czech Republic|C LF23-0121 06 01 Site 204, Bailleul, France|C LF23-0121 06 01 Site 200, Bondy, France|C LF23-0121 06 01 Site 207, Cholet, France|C LF23-0121 06 01 Site 208, Evreux, France|C LF23-0121 06 01 Site 201, Pantin, France|C LF23-0121 06 01 Site 202, Tours, France|C LF23-0121 06 01 Site 205, Wattrelos, France|C LF23-0121 06 01 Site 406, Balatonfüred, Hungary|C LF23-0121 06 01 Site 400, Budapest, Hungary|C LF23-0121 06 01 Site 401, Budapest, Hungary|C LF23-0121 06 01 Site 402, Budapest, Hungary|C LF23-0121 06 01 Site 403, Budapest, Hungary|C LF23-0121 06 01 Site 405, Budapest, Hungary|C LF23-0121 06 01 Site 407, Budapest, Hungary|C LF23-0121 06 01 Site 408, Budapest, Hungary|C LF23-0121 06 01 Site 404, Debrecen, Hungary|C LF23-0121 06 01 Site 501, Bangalore, India|C LF23-0121 06 01 Site 504, Bangalore, India|C LF23-0121 06 01 Site 516, Bangalore, India|C LF23-0121 06 01 Site 519, Bangalore, India|C LF23-0121 06 01 Site 508, Chennai, India|C LF23-0121 06 01 Site 510, Chennai, India|C LF23-0121 06 01 Site 505, Hyderabad, India|C LF23-0121 06 01 Site 509, Hyderabad, India|C LF23-0121 06 01 Site 517, Hyderabad, India|C LF23-0121 06 01 Site 511, Karnataka, India|C LF23-0121 06 01 Site 512, Maharashtra, India|C LF23-0121 06 01 Site 502, Mumbai, India|C LF23-0121 06 01 Site 503, Mumbai, India|C LF23-0121 06 01 Site 518, Nasik, India|C LF23-0121 06 01 Site 506, Pune, India|C LF23-0121 06 01 Site 514, Tiruvanathapuram-Kerala, India|C LF23-0121 06 01 Site 800, Vilnius, Lithuania|C LF23-0121 06 01 Site 801, Vilnius, Lithuania|C LF23-0121 06 01 Site 802, Vilnius, Lithuania|C LF23-0121 06 01 Site 600, Bialystok, Poland|C LF23-0121 06 01 Site 613, Bydgoszcz, Poland|C LF23-0121 06 01 Site 618, Grudziadz, Poland|C LF23-0121 06 01 Site 603, Katowice, Poland|C LF23-0121 06 01 Site 601, Kraków, Poland|C LF23-0121 06 01 Site 607, Kraków, Poland|C LF23-0121 06 01 Site 610, Kraków, Poland|C LF23-0121 06 01 Site 615, Kutno, Poland|C LF23-0121 06 01 Site 605, Olsztyn, Poland|C LF23-0121 06 01 Site 604, Opole, Poland|C LF23-0121 06 01 Site 606, Poznan, Poland|C LF23-0121 06 01 Site 609, Poznan, Poland|C LF23-0121 06 01 Site 621, Sliwinska, Poland|C LF23-0121 06 01 Site 617, Starogard Gdanski, Poland|C LF23-0121 06 01 Site 616, Szczecin, Poland|C LF23-0121 06 01 Site 602, Warszawa, Poland|C LF23-0121 06 01 Site 608, Warszawa, Poland|C LF23-0121 06 01 Site 619, Warszawa, Poland|C LF23-0121 06 01 Site 620, Warszawa, Poland|C LF23-0121 06 01 Site 611, Wroclaw, Poland|C LF23-0121 06 01 Site 612, Wroclaw, Poland|C LF23-0121 06 01 Site 614, Zgierz, Poland|C LF23-0121 06 01 Site 700, Bratislava, Slovakia|C LF23-0121 06 01 Site 703, Kosice, Slovakia|C LF23-0121 06 01 Site 702, Lucenec, Slovakia|C LF23-0121 06 01 Site 701, Skalica, Slovakia
URL: https://clinicaltrials.gov/show/NCT00362323

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