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DyslipidemiasTREZETENCT04862962

Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia

An observational study of Dyslipidemias, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dyslipidemias
What is being tested?
Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose
Type of treatment
Pill or oral medicine
How many people
120 participants
Where
1 siteMexico
Study dates
30 Sep 2021to 15 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Laboratorio Silanes, S.A. de C.V.

    Mexico City, 11000

Other trials in Mexico

About this study

Official title: Retrospective Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin / Ezetimibe as a Treatment for Patients With Dyslipidaemia in Usual Medical Practice.

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.

Read the detailed description

To assess the safety of the fixed-dose combination of rosuvastatin / ezetimibe in subjects older than 18 years of age (gender indistinct) with dyslipidemia who at the discretion have been candidates for treatment with the combination. For the safety analysis, all the research subjects who have taken rosuvastatin / ezetimibe will be considered. The information recorded by the treating physicians in the file will be reviewed and within the case report format (CRF) of all adverse events that occur in the study. The terms originally used in the case report format by the investigators to identify adverse events (AE) will be coded in the analysis stage of Results using the current MEdDRA dictionary. The incidence of AE will be synthesized such as the frequency count and percentage of research subjects with events adverse by organ / system.

Conditions
Dyslipidemias
Being tested
Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose
Keywords
Dyslipidemias, Combine therapy, Lower Cholesterol, Lipids
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed DoseDrug

    Also called (TREZETE®)

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

Study groups in NCT04862962
Study groupRoleWhat they receive
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
Receives: Drug: Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events presented

    Describe the frequency and intensity of adverse events presented.

    Measured: 2 months

  2. Average difference in lipid profile values

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

    Measured: Baseline, 2 months

Secondary outcomes (3)

  1. Adherence to treatment

    To assess adherence to treatment with rosuvastatin / ezetimibe fixed-dose combination by pill count.

    Measured: 2 months

  2. Significant reduction in LDL cholesterol

    To assess the proportion of subjects who achieved a significant reduction in LDL cholesterol at each concentration of treatment.

    Measured: 2 months

  3. Percentage of patients who met established goals according to cardiovascular risk

    To identify the percentage of patients who met the established goals according to cardiovascular risk determined by the European Society of Cardiology (ESC) and / or American Heart Association (AHA) / American College of Cardiology (ACC) recommendations.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2021
  2. Study start30 Sep 2021
  3. Primary completion15 Jan 2022
  4. Study completion15 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04862962
Sponsor's protocol ID
SIL-30231-IV-20(1)
Acronym
TREZETE
Status last verified
Feb 2022
First submitted
23 Apr 2021
Last updated
2 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17162426

  • 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.

    PubMed 21346920

  • 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.

    PubMed 24603993

  • 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.

    PubMed 30375494

  • 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.

    PubMed 22442638

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

    PubMed 15531000

  • 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.

    PubMed 19436657

  • 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.

    PubMed 21267417

  • 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.

    PubMed 25915909

  • 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.

    PubMed 17317370

  • 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.

    PubMed 36124294

Questions about this trial

What is this clinical trial studying?

An observational study of Dyslipidemias, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events presented (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04862962, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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