Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT04882293
Status:
UNKNOWN
Last Update Posted:
2022-03-02
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of change in lipid profile figures.', 'timeFrame': 'Baseline, 2 and 4 months.', 'description': 'To assess the magnitude of change in lipid profile figures (Lp \\[a\\], LDL, and triglycerides) at 2 and 4 months with respect to their baseline measurement and between treatment groups.'}, {'measure': 'Proportion of subjects achieving triglyceride levels <150 mg /dL.', 'timeFrame': '4 months', 'description': 'Describe the proportion of subjects who achieved triglyceride levels \\<150 mg / dL at the end of treatment.'}, {'measure': 'Describe the proportion of subjects who reduced levels of LDL cholesterol', 'timeFrame': 'Baseline and 4 months.', 'description': 'Describe the proportion of subjects who reduced levels of LDL cholesterol, under 30% compare to the baseline value.'}], 'secondaryOutcomes': [{'measure': 'Impact on anthropometric indicators (Weight)', 'timeFrame': 'Baseline and 4 Months', 'description': 'Describe changes in weight (kg) measurements from baseline to the end of the study (4 months).'}, {'measure': 'Impact on anthropometric indicators body mass index (BMI)', 'timeFrame': 'Baseline and 4 months', 'description': 'Describe changes in BMI (kg/m2) from baseline to the end of the study (4 months)'}, {'measure': 'Impact on anthropometric indicators (Waist circumference)', 'timeFrame': 'Baseline and 4 months', 'description': 'Describe changes in waist circumference (cm) from baseline to the end of the study (4 months).'}, {'measure': 'Impact on liver function with aspartate aminotransferas (AST)', 'timeFrame': 'Baseline and 4 months', 'description': 'Describe the changes in AST (mg/dL) concentration, between baseline and the end of the study.'}, {'measure': 'Impact on liver function with Alanine Aminotransferase (ALT)', 'timeFrame': 'Baseline and 4 months', 'description': 'Describe the changes in ALT (mg/dL) concentration, between baseline and the end of the study.'}, {'measure': 'Impact on Glycosylated hemoglobin (HbA1c)', 'timeFrame': 'Baseline and 4 months', 'description': 'Describe the changes in HbA1c percentage from baseline to the end of the study (4 months).'}, {'measure': 'Impact on glucose levels', 'timeFrame': 'Baseline and 4 months', 'description': 'Describe the changes in glucose levels (mg/dL) from baseline to the end of the study (4 months).'}, {'measure': 'Impact on Blood pressure', 'timeFrame': 'Baseline and 4 months', 'description': 'Describe the changes in blood pressure (mm Hg) from baseline to the end of the study (4 months). impact on clinical indicators (Blood pressure, Heart rate, Respiratory rate).'}, {'measure': 'Impact on heart rate', 'timeFrame': 'Baseline and 4 months', 'description': 'Describe the changes in heart rate (beats per minute) from baseline to the end of the study (4 months).'}, {'measure': 'Impact on respiratory rate', 'timeFrame': 'Baseline and 4 months', 'description': 'Describe the changes in respiratory rate (Pulses per minute) from baseline to the end of the study (4 months).'}, {'measure': 'Events and adverse reactions presented.', 'timeFrame': '4 months', 'description': 'Proportion of events and adverse reactions presented during 4 months of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dyslipidemia', 'Type 2 diabetes', 'Hypertriglyceridemia', 'Lipid profile'], 'conditions': ['Dyslipidemia Associated With Type II Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24603993', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24516261', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24083205', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12087019', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '40323331', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.dof.gob.mx/nota_detalle.php?codigo=5259329&fecha=13/07/2012', 'label': 'NOM. 037-SSA2-2012 para la prevención, tratamiento y control de las dislipidemias. México: Diario Oficial de la Federación. 2012;13.'}]}, 'descriptionModule': {'briefSummary': 'Phase IIIb, randomized, longitudinal, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia.', 'detailedDescription': 'To assess the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia. Assessing the magnitude of change in lipid profile numbers. And describing the effect on anthropometric, biochemical and clinical indicators, as well as events and adverse reactions that may occur. In patients diagnosed with type 2 diabetes and dyslipidemia (triglycerides\\> 150 mg / dl, LDL (Low density lipoprotein) cholesterol\\> 100 mg / dl) and who require pharmacological treatment for lipid control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* That the subject agrees to participate in the study and gives their informed consent in writing.\n* Both genres.\n* Age 18 to 75 years old.\n* Diagnosis of type 2 diabetes mellitus with adequate glycemic control defined by HbA1c ≤ 7.5% at the time of selection.\n* Diagnosis of dyslipidemia prior to the start of the study (LDL cholesterol\\> 100 mg / dl and triglycerides\\> 150 mg / dl).\n* Willing to avoid sexual contact or to use a barrier method of contraception while conducting the study.\n\nExclusion Criteria:\n\n* The drug is contraindicated for medical reasons.\n* Consumption of oral contraceptives, cyclosporine or strong cytochrome p450 (CYP) 3A4 inhibitors, protease inhibitors, erythromycin and azoles.\n* Patients with Type 1 Diabetes Mellitus.\n* Acute or Severe renal dysfunction (glomerular filtration \\<30 ml / min / 1.72 m2).\n* 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.\n* 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).\n* Patients with active gallbladder disease (defined as acute or chronic gallbladder disorders associated with clinical signs or symptoms).\n* Patient with a history or presence of myopathies.\n* Pregnant or lactating women.\n* Known contraindication or hypersensitivity to the use of any of the components of the investigational drug.\n* The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.\n* 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.\n* Be a patient with a working relationship with the principal investigator or the research center or prisoner.'}, 'identificationModule': {'nctId': 'NCT04882293', 'briefTitle': 'Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Silanes S.A. de C.V.'}, 'officialTitle': 'Confirmatory Study of the Efficacy and Safety of the Fixed-dose Combination Atorvastatin / Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients With Type 2 Diabetes (T2D) and Dyslipidaemia (DLP).', 'orgStudyIdInfo': {'id': 'SIL-30301-III-20(1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Atorvastatin / Fenofibrate in fixed dose', 'description': 'Group A: Atorvastatin / Fenofibrate in fixed dose Pharmaceutical Form: Tablets Dosage: 20 mg /160 mg Adminstration way: Oral', 'interventionNames': ['Drug: Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Atorvastatin (Lipitor ®)', 'description': 'Group B: Atorvastatin (Lipitor ®) Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration wat: Oral', 'interventionNames': ['Drug: Atorvastatin (Lipitor ®)']}], 'interventions': [{'name': 'Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose', 'type': 'DRUG', 'otherNames': ['ATV / FENO'], 'description': '1 tablet once a day, 20 mg /160 mg, Orally', 'armGroupLabels': ['Group A: Atorvastatin / Fenofibrate in fixed dose']}, {'name': 'Atorvastatin (Lipitor ®)', 'type': 'DRUG', 'otherNames': ['ATV (Lipitor ®)'], 'description': '1 tablet once a day, 20 mg, Orally', 'armGroupLabels': ['Group B: Atorvastatin (Lipitor ®)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Jorge A Gonzalez, PhD', 'role': 'CONTACT', 'email': 'jogonzalez@silanes.com.mx', 'phone': '+5254883785', 'phoneExt': '3761'}, {'name': 'Yulia Romero-Antonio, B.S.', 'role': 'CONTACT', 'email': 'yromero@silanes.com.mx', 'phone': '5554883700', 'phoneExt': '3777'}, {'name': 'Alberto J Zamora Muciño-Arroyo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joel Rodríguez Saldaña, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Francisco G Padilla Padilla, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Juan A Peraza Zaldicar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luis M Román Pintos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laboratorio Silanes, S.A. de C.V.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Jorge A González, PhD', 'role': 'CONTACT', 'email': 'jogonzalez@silanes.com.mx', 'phone': '5254883785', 'phoneExt': '3761'}, {'name': 'Yulia G Romero-Antonio, B.S.', 'role': 'CONTACT', 'email': 'yromero@silanes.com.mx', 'phone': '5554883700', 'phoneExt': '3777'}], 'overallOfficials': [{'name': 'Alberto J Zamora Muciño-Arroyo, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)'}, {'name': 'Joel Rodríguez Saldaña, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resultados médicos, desarrollo e investigación SC (REMEDI)'}, {'name': 'Francisco G Padilla Padilla, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Independent'}, {'name': 'Juan A Peraza Zaldivar, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)'}, {'name': 'Luis M Román Pintos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Hispano S.A de C.V'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Silanes S.A. de C.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}