Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia
NCT ID: NCT04862962
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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COMPLETED
120 participants
OBSERVATIONAL
2021-09-30
2022-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Group A: Rosuvastatin /Ezetimibe fixed dose (TREZETE®)
Rosuvastatin /Ezetimibe fixed dose (TREZETE®) Pharmaceutical Form: Tablets Dosage: 10 mg / 10 mg or 20 mg / 10 mg Administration way: Oral
Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose
Oral Tablets 10 mg/10 mg or 20 mg/10 mg
Interventions
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Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose
Oral Tablets 10 mg/10 mg or 20 mg/10 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of dyslipidemia.
* That treatment with the fixed-dose combination of rosuvastatin / ezetimibe is documented.
* Have security questioning on at least two occasions.
Exclusion Criteria
18 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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Joel Rodriguez Saldaña, M.D
Role: PRINCIPAL_INVESTIGATOR
Resultados Médicos, desarrollo e Investigación
Francisco G Padilla Padilla, M.D
Role: PRINCIPAL_INVESTIGATOR
Independent
Ernesto G Cardona Muñoz, M.D
Role: PRINCIPAL_INVESTIGATOR
Independent
David Cardona Müller, M.D
Role: PRINCIPAL_INVESTIGATOR
Independent
Marcos Ibarra Flores, M.D
Role: PRINCIPAL_INVESTIGATOR
Cardiólogos Certificados S.C
José A Estrada Suarez, M.D
Role: PRINCIPAL_INVESTIGATOR
Independent
Locations
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Laboratorio Silanes, S.A. de C.V.
Mexico City, , Mexico
Countries
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References
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Garcia-Garcia G, Aviles-Gomez R, Luquin-Arellano VH, Padilla-Ochoa R, Lepe-Murillo L, Ibarra-Hernandez M, Briseno-Renteria G. Cardiovascular risk factors in the Mexican population. Ren Fail. 2006;28(8):677-87. doi: 10.1080/08860220600936096.
Roth GA, Fihn SD, Mokdad AH, Aekplakorn W, Hasegawa T, Lim SS. High total serum cholesterol, medication coverage and therapeutic control: an analysis of national health examination survey data from eight countries. Bull World Health Organ. 2011 Feb 1;89(2):92-101. doi: 10.2471/BLT.10.079947. Epub 2010 Sep 3.
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.
Adhyaru BB, Jacobson TA. Safety and efficacy of statin therapy. Nat Rev Cardiol. 2018 Dec;15(12):757-769. doi: 10.1038/s41569-018-0098-5.
Luvai A, Mbagaya W, Hall AS, Barth JH. Rosuvastatin: a review of the pharmacology and clinical effectiveness in cardiovascular disease. Clin Med Insights Cardiol. 2012;6:17-33. doi: 10.4137/CMC.S4324. Epub 2012 Feb 1.
Cheng JW. Rosuvastatin in the management of hyperlipidemia. Clin Ther. 2004 Sep;26(9):1368-87. doi: 10.1016/j.clinthera.2004.09.005.
Rubba P, Marotta G, Gentile M. Efficacy and safety of rosuvastatin in the management of dyslipidemia. Vasc Health Risk Manag. 2009;5(1):343-52. doi: 10.2147/vhrm.s3662. Epub 2009 Apr 8.
Kones R. Rosuvastatin, inflammation, C-reactive protein, JUPITER, and primary prevention of cardiovascular disease--a perspective. Drug Des Devel Ther. 2010 Dec 9;4:383-413. doi: 10.2147/DDDT.S10812.
Battaggia A, Donzelli A, Font M, Molteni D, Galvano A. Clinical efficacy and safety of Ezetimibe on major cardiovascular endpoints: systematic review and meta-analysis of randomized controlled trials. PLoS One. 2015 Apr 27;10(4):e0124587. doi: 10.1371/journal.pone.0124587. eCollection 2015.
Ballantyne CM, Weiss R, Moccetti T, Vogt A, Eber B, Sosef F, Duffield E; EXPLORER Study Investigators. Efficacy and safety of rosuvastatin 40 mg alone or in combination with ezetimibe in patients at high risk of cardiovascular disease (results from the EXPLORER study). Am J Cardiol. 2007 Mar 1;99(5):673-80. doi: 10.1016/j.amjcard.2006.10.022. Epub 2007 Jan 4.
Rodriguez-Saldana J, Padilla-Padilla F, Cardona-Munoz EG, Romero-Antonio Y, Arguedas-Nunez MM, Sander-Padilla JG, Martinez-Munoz A, Lugo-Sanchez LA, Rodriguez-Vazquez IC, Gonzalez-Canudas J. Real-World Evidence Evaluation on the Lipid Profile, Therapeutic Goals, and Safety of the Fixed-Dose Combination of Rosuvastatin/Ezetimibe (Trezete(R)) in Dyslipidemia Patients. Cardiol Res Pract. 2022 Sep 10;2022:9464733. doi: 10.1155/2022/9464733. eCollection 2022.
Other Identifiers
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SIL-30231-IV-20(1)
Identifier Type: -
Identifier Source: org_study_id
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