Fenofibrate and Metformin Fixed Combination vs Rosiglitazone - FAME ROSI
NCT ID: NCT00361868
Last Updated: 2008-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
88 participants
INTERVENTIONAL
2006-06-30
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
fenofibrate (F) + metformin (M) hydrochloride fixed combination
First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks
2
Rosiglitazone
First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fenofibrate (F) + metformin (M) hydrochloride fixed combination
First period: F80mg/M500mg - per os - twice a day during 2 weeks and F80mg/M850mg - per os - twice a day during 10 weeks - Second period: F54mg/M850mg - per os - three times a day during 12 weeks
Rosiglitazone
First period: 4 mg - per os - daily during 12 weeks - Second period: 4 mg - per os - twice a day during 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Solvay Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Solvay Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site105
Pula, , Croatia
Site102
Rijeka, , Croatia
Site103
Split, , Croatia
Site104
Varaždin, , Croatia
Site100
Zagreb, , Croatia
Site101
Zagreb, , Croatia
Site 205
Jyväskylä, , Finland
Site 206
Kokkola, , Finland
Site 208
Laukaa, , Finland
Site 207
Oulu, , Finland
Site 303
Bassens, , France
Site 307
Bordeaux, , France
Site 305
Mûrs-Erigné, , France
Site 302
Seysses, , France
Site 304
Strasbourg, , France
Site 301
Thouars, , France
Site 306
Vihiers, , France
Site 405
Berlin, , Germany
Site 410
Borna, , Germany
Site 403
Bretten, , Germany
Site 402
Dresden, , Germany
Site 404
Frankfurt, , Germany
Site 400
Freiburg im Breisgau, , Germany
Site 401
Hanover, , Germany
Site 409
Ilvesheim, , Germany
Site 411
Ilvesheim, , Germany
Site 407
Leipzig, , Germany
Site 406
Rodgau, , Germany
Site 413
Rotenburg (Wümme), , Germany
Site 408
Schwerin, , Germany
Site 412
Villingen-Schwenningen, , Germany
Site 509
Almere Stad, , Netherlands
Site 502
Breda, , Netherlands
Site 503
Eindhoven, , Netherlands
Site 504
Groningen, , Netherlands
Site 505
Leiden, , Netherlands
Site 506
Nijmegen, , Netherlands
Site 500
Rotterdam, , Netherlands
Site 507
Velp, , Netherlands
Site 508
Zoetermeer, , Netherlands
Site 610
Bialystok, , Poland
Site 606
Elblag, , Poland
Site 608
Gdansk, , Poland
Site 600
Lodz, , Poland
Site 605
Otolinska, , Poland
Site 604
Radom, , Poland
Site 613
Starogard Gdański, , Poland
Site 601
Warsaw, , Poland
Site 607
Warsaw, , Poland
Site 612
Warsaw, , Poland
Site 602
Wroclaw, , Poland
Site 603
Wroclaw, , Poland
Site 704
Brasov, , Romania
Site 701
Bucharest, , Romania
Site 703
Bucharest, , Romania
Site 700
Cluj-Napoca, , Romania
Site 702
Iași, , Romania
Site 705
Târgu Mureş, , Romania
Site 807
Kharkiv, , Ukraine
Site 811
Kharkiv, , Ukraine
Site 812
Kharkiv, , Ukraine
Site 800
Kiev, , Ukraine
Site 803
Kiev, , Ukraine
Site 808
Kiev, , Ukraine
Site 809
Kiev, , Ukraine
Site 810
Kiev, , Ukraine
Site 813
Kiev, , Ukraine
Site 805
Lviv, , Ukraine
Site 804
Odesa, , Ukraine
Site 802
Vinnitsa, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2005-006060-63
Identifier Type: -
Identifier Source: secondary_id
C LF23-0121 05 01
Identifier Type: -
Identifier Source: org_study_id