NCT04862962

Brief Summary

Retrospective, analytical, longitudinal, multicenter study to evaluate the safety of the fixed-dose combination of rosuvastatin / ezetimibe as treatment for patients with dyslipidemia in routine medical practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

April 23, 2021

Last Update Submit

February 28, 2022

Conditions

Dyslipidemias

Keywords

DyslipidemiasCombine therapyLower CholesterolLipids

Outcome Measures

Primary Outcomes (2)

  • Adverse events presented

    Describe the frequency and intensity of adverse events presented.

    2 months

  • Average difference in lipid profile values

    Evaluate the average difference in lipid profile values between at least 2 measurements.

    Baseline, 2 months

Secondary Outcomes (3)

  • Adherence to treatment

    2 months

  • Significant reduction in LDL cholesterol

    2 months

  • Percentage of patients who met established goals according to cardiovascular risk

    2 months

Study Arms (1)

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

Drug: Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose

Interventions

Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed DoseDRUG

Oral Tablets 10 mg/10 mg or 20 mg/10 mg

Also known as: (TREZETE®)
Group A: Rosuvastatin /Ezetimibe fixed dose (TREZETE®)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects over 18 years of age (gender indistinct) with dyslipidemia who, at the discretion of thetreating physician have been candidates for treatment with the fixed-dose combination of rosuvastatin-ezetimibe.

You may qualify if:

  • Age\> 18 years of age.
  • Diagnosis of dyslipidemia.
  • That treatment with the fixed-dose combination of rosuvastatin / ezetimibe is documented.
  • Have security questioning on at least two occasions.

You may not qualify if:

  • Subjects who has taken any other statins, fibrates, bile acid sequestrants, niacin (\> 500 mg) or inhibitors of PCSK9 concomitantly during treatment with rosuvastatin / ezetimibe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, 11000, Mexico

Location

Related Publications (11)

  • 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.

    PMID: 17162426BACKGROUND

  • 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.

    PMID: 21346920BACKGROUND

  • 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: 24603993BACKGROUND

  • 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.

    PMID: 30375494BACKGROUND

  • 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.

    PMID: 22442638BACKGROUND

  • Cheng JW. Rosuvastatin in the management of hyperlipidemia. Clin Ther. 2004 Sep;26(9):1368-87. doi: 10.1016/j.clinthera.2004.09.005.

    PMID: 15531000BACKGROUND

  • 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.

    PMID: 19436657BACKGROUND

  • 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.

    PMID: 21267417BACKGROUND

  • 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.

    PMID: 25915909BACKGROUND

  • 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.

    PMID: 17317370BACKGROUND

  • 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.

    PMID: 36124294DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joel Rodriguez Saldaña, M.D

    Resultados Médicos, desarrollo e Investigación

    PRINCIPAL INVESTIGATOR

  • Francisco G Padilla Padilla, M.D

    Independent

    PRINCIPAL INVESTIGATOR

  • Ernesto G Cardona Muñoz, M.D

    Independent

    PRINCIPAL INVESTIGATOR

  • David Cardona Müller, M.D

    Independent

    PRINCIPAL INVESTIGATOR

  • Marcos Ibarra Flores, M.D

    Cardiólogos Certificados S.C

    PRINCIPAL INVESTIGATOR

  • José A Estrada Suarez, M.D

    Independent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2021

First Posted

April 28, 2021

Study Start

September 30, 2021

Primary Completion

January 15, 2022

Study Completion

February 15, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)