Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.
NCT ID: NCT04882293
Last Updated: 2022-03-02
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
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UNKNOWN
PHASE3
78 participants
INTERVENTIONAL
2022-02-15
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A: Atorvastatin / Fenofibrate in fixed dose
Group A: Atorvastatin / Fenofibrate in fixed dose Pharmaceutical Form: Tablets Dosage: 20 mg /160 mg Adminstration way: Oral
Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose
1 tablet once a day, 20 mg /160 mg, Orally
Group B: Atorvastatin (Lipitor ®)
Group B: Atorvastatin (Lipitor ®) Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration wat: Oral
Atorvastatin (Lipitor ®)
1 tablet once a day, 20 mg, Orally
Interventions
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Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose
1 tablet once a day, 20 mg /160 mg, Orally
Atorvastatin (Lipitor ®)
1 tablet once a day, 20 mg, Orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both genres.
* Age 18 to 75 years old.
* Diagnosis of type 2 diabetes mellitus with adequate glycemic control defined by HbA1c ≤ 7.5% at the time of selection.
* Diagnosis of dyslipidemia prior to the start of the study (LDL cholesterol\> 100 mg / dl and triglycerides\> 150 mg / dl).
* Willing to avoid sexual contact or to use a barrier method of contraception while conducting the study.
Exclusion Criteria
* Consumption of oral contraceptives, cyclosporine or strong cytochrome p450 (CYP) 3A4 inhibitors, protease inhibitors, erythromycin and azoles.
* Patients with Type 1 Diabetes Mellitus.
* Acute or Severe renal dysfunction (glomerular filtration \<30 ml / min / 1.72 m2).
* History of chronic liver disease or ALT and / or AST ≥ 2 times the upper limit of normal, or GGT ≥3 times the upper limit of normal.
* Chronic or acute pancreatitis except for acute pancreatitis due to severe hypertriglyceridemia (defined by the presence of triglycerides\> 1000 mg / dl and / or milky plasma, in the absence of other etiological factors of pancreatitis).
* Patients with active gallbladder disease (defined as acute or chronic gallbladder disorders associated with clinical signs or symptoms).
* Patient with a history or presence of myopathies.
* Pregnant or lactating women.
* Known contraindication or hypersensitivity to the use of any of the components of the investigational drug.
* The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
* At the medical discretion, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: end-stage cancer, kidney, heart, respiratory or liver or mental failure or with scheduled surgical or hospital procedures.
* Be a patient with a working relationship with the principal investigator or the research center or prisoner.
18 Years
75 Years
ALL
Yes
Sponsors
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Laboratorios Silanes S.A. de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Alberto J Zamora Muciño-Arroyo, M.D
Role: PRINCIPAL_INVESTIGATOR
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)
Joel Rodríguez Saldaña, M.D
Role: PRINCIPAL_INVESTIGATOR
Resultados médicos, desarrollo e investigación SC (REMEDI)
Francisco G Padilla Padilla, M.D
Role: PRINCIPAL_INVESTIGATOR
Independent
Juan A Peraza Zaldivar, M.D
Role: PRINCIPAL_INVESTIGATOR
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)
Luis M Román Pintos, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Hispano S.A de C.V
Locations
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Laboratorio Silanes, S.A. de C.V.
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Escobedo-de la Pena J, de Jesus-Perez R, Schargrodsky H, Champagne B. [Prevalence of dyslipidemias in Mexico city and Its relation to other cardiovascular risk factors. Results from the CARMELA study]. Gac Med Mex. 2014 Mar-Apr;150(2):128-36. Spanish.
Harivenkatesh N, David DC, Haribalaji N, Sudhakar MK. Efficacy and safety of alternate day therapy with atorvastatin and fenofibrate combination in mixed dyslipidemia: a randomized controlled trial. J Cardiovasc Pharmacol Ther. 2014 May;19(3):296-303. doi: 10.1177/1074248413518968. Epub 2014 Feb 10.
Lella M, Indira K. A comparative study of efficacy of atorvastatin alone and its combination with fenofibrate on lipid profile in type 2 diabetes mellitus patients with hyperlipidemia. J Adv Pharm Technol Res. 2013 Jul;4(3):166-70. doi: 10.4103/2231-4040.116778.
Athyros VG, Papageorgiou AA, Athyrou VV, Demitriadis DS, Kontopoulos AG. Atorvastatin and micronized fenofibrate alone and in combination in type 2 diabetes with combined hyperlipidemia. Diabetes Care. 2002 Jul;25(7):1198-202. doi: 10.2337/diacare.25.7.1198.
Padilla-Padilla FG, Ruiz-Bernes LN, Roman-Pintos LM, Peraza-Zaldivar JA, Sander-Padilla JG, Lugo-Sanchez LA, Rios-Brito KF, Arguedas-Nunez MM, Flores-Huanosta D, Gonzalez-Canudas J. Efficacy and Safety of the Fixed-Dose Combination of Atorvastatin/Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients with Type 2 Diabetes and Dyslipidemia. Cardiol Ther. 2025 Jun;14(2):297-314. doi: 10.1007/s40119-025-00410-y. Epub 2025 May 5.
Related Links
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NOM. 037-SSA2-2012 para la prevención, tratamiento y control de las dislipidemias. México: Diario Oficial de la Federación. 2012;13.
Other Identifiers
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SIL-30301-III-20(1)
Identifier Type: -
Identifier Source: org_study_id
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