A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.
NCT ID: NCT00703755
Last Updated: 2008-06-25
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.
COMPLETED
PHASE2
2288 participants
INTERVENTIONAL
2003-03-31
2004-06-30
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
FACTORIAL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700)
2
Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000)
3
Fenofibrate /Metformin
fenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700)
4
Fenofibrate /Metformin
fenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000)
5
Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin placebo (F160-M0)
6
Fenofibrate /Metformin
fenofibrate placebo + metformin 850 mg bid (F0-M1700)
7
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700)
Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000)
Fenofibrate /Metformin
fenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700)
Fenofibrate /Metformin
fenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000)
Fenofibrate /Metformin
fenofibrate 2 x 40 mg bid + metformin placebo (F160-M0)
Fenofibrate /Metformin
fenofibrate placebo + metformin 850 mg bid (F0-M1700)
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* With 3 of the following 5 criteria, including at least 2 biochemical abnormalities (glucose and one lipid abnormality)
* And having signed a written informed consent (at inclusion V1).
Exclusion Criteria
* wth HbA1c \> 8 % \[27\] at the first blood sample;
* body mass index (BMI) \> 45 kg/m2;
* females who were not surgically sterilized or not using adequate contraceptive or not using adequate contraceptive precautions or not postmenopausal
* pregnant or lactating women;
* known hypersensitivity to fibrates;
* known hypersensitivity to metformin chlorhydrate; known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level;
* having received an investigational drug in the last 30 days before the date of randomization;
* unable or unwilling to comply with the protocol;
* likely to withdraw from the study before its completion;
* treated with some concomitant medications:
* reporting a change within the last 6 weeks before randomization and during the study in the medications that could interfere with the lipid profile (i.e., anti-hypertensive drugs, oral corticosteroids, thyroid hormones, retinoids, thiazidic derivatives, hormone replacement therapies);
* presenting with the following disease or conditions:
* chronic respiratory insufficiency, patient with medical device for sleep apnea;
* current chronic pancreatitis, or identified risk or known history of acute pancreatitis;
* hepatic insufficiency, acute alcohol intoxication, alcoholism;
* known cholelithiasis without cholecystectomy;
* aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2 times the upper limit normal (ULN);
* musculoskeletal disease or increased creatine phosphokinase (CPK) \> 3 times the ULN;
* renal failure or renal dysfunction defined by serum creatinine levels \> 135 μmol/L in males and \> 110 μmol/L in females \[28\];
* acute conditions with the potential to alter renal function such as dehydration, severe infection, shock or intravascular administration of iodinated contrast agents;
* acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction (within 3 months prior to randomization), shock;
* known gastric or peptic ulcer or intestinal disease within the previous 3 months of randomization capable of modifying the intestinal absorption of the drugs;
* any other severe pathology such as cancer, mental illness, etc., which in the opinion of the investigator might pose a risk to the patient or confound the results of the study
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.
Site 013
Calgary, Alberta, Canada
Site 019
Calgary, Alberta, Canada
Site 007
Chicoutimi, , Canada
Site 024
Halifax, , Canada
Site 004
Hamilton, , Canada
Site 012
Kingston, , Canada
Site 017
Longueuil, , Canada
Site 009
Montague, , Canada
Site 001
Montreal, , Canada
Site 015
Montreal, , Canada
Site 003
Québec, , Canada
Site 025
Sainte-Foy, , Canada
Site 026
Sainte-Foy, , Canada
Site 021
Sherbrooke, , Canada
Site 010
St. John's, , Canada
Site 020
St. John's, , Canada
Site 022
St. John's, , Canada
Site 006
Ste-Foy, , Canada
Site 016
Toronto, , Canada
Site 005
Vancouver, , Canada
Site 011
Victoria, , Canada
Site 090
Hus, , Finland
Site 091
Jakobstad, , Finland
Site 095
Jyväskylä, , Finland
Site 092
Mikkeli, , Finland
Site 096
Närpes, , Finland
Site 094
Vaasa, , Finland
Site 190
Budapest, , Hungary
Site 191
Budapest, , Hungary
Site 193
Budapest, , Hungary
Site 199
Budapest, , Hungary
Site 202
Budapest, , Hungary
Site 204
Budapest, , Hungary
Site 203
Debrecen, , Hungary
Site 200
Gyöngyös, , Hungary
Site 201
Győr, , Hungary
Site 198
Gyula, , Hungary
Site 197
Miskolc, , Hungary
Site 196
Pécs, , Hungary
Site 194
Szeged, , Hungary
Site 192
Székesfehérvár, , Hungary
Site 205
Szombathely, , Hungary
Site 195
Veszprém, , Hungary
Site 074
Catanzaro, , Italy
Site 077
Chieti Scalo, , Italy
Site 075
Padua, , Italy
Site 076
Padua, , Italy
Site 073
Palermo, , Italy
Site 072
Perugia, , Italy
Site 070
Treviglio Bergamo, , Italy
Site 044
Almere Stad, , Netherlands
Site 040
Amsterdam-Zuidoost, , Netherlands
Site 054
Den Helder, , Netherlands
Site 057
Dordrecht, , Netherlands
Site 042
Eindhoven, , Netherlands
Site 045
Groningen, , Netherlands
Site 052
Groningen, , Netherlands
Site 041
Hoorn, , Netherlands
Site 046
Leiden, , Netherlands
Site 047
Rotterdam, , Netherlands
Site 051
Rotterdam, , Netherlands
Site 043
Sliedrecht, , Netherlands
Site 055
Tiel, , Netherlands
Site 053
Veldhoven, , Netherlands
Site 048
Velp, , Netherlands
Site 056
Velp, , Netherlands
Site 049
Zoetermeer, , Netherlands
Site 060
Zwijndrecht, , Netherlands
Site 117
Elverum, , Norway
Site 114
Hobol, , Norway
Site 111
Horten, , Norway
Site 110
Oslo, , Norway
Site 112
Oslo, , Norway
Site 113
Oslo, , Norway
Site 118
Oslo, , Norway
Site 115
Skedsmokorset, , Norway
Site 130
Brodnowski, , Poland
Site 139
Chrzanów, , Poland
Site 134
Gdansk, , Poland
Site 132
Katowice, , Poland
Site 131
Kielce, , Poland
Site 135
Olsztyn, , Poland
Site 138
Ul. Ziolowa, , Poland
Site 133
Warsaw, , Poland
Site 220
Brasov, , Romania
Site 210
Bucharest, , Romania
Site 211
Bucharest, , Romania
Site 212
Bucharest, , Romania
Site 214
Bucharest, , Romania
Site 218
Bucharest, , Romania
Site 219
Bucharest, , Romania
Site 215
Cluj-Napoca, , Romania
Site 213
Craiova, , Romania
Site 217
Iași, , Romania
Site 216
Suceava, , Romania
Site 153
Gothenburg, , Sweden
Site 154
Kristianstad, , Sweden
Site 150
Linköping, , Sweden
Site 155
Lund, , Sweden
Site 152
Stockholm, , Sweden
Site 151
Umeå, , Sweden
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.
CFEN0203
Identifier Type: -
Identifier Source: org_study_id