Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment

Dyslipidemia Clinical Trial

Official title:

Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03527069
• Other study ID #: EMS0617-CIPROS
• Status: Recruiting
• Phase: Phase 3
• Start date: January 29, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: EMS
• Contact: Monalisa F.B. Oliveira, MD
• Phone: +551938879851
• Email: pesquisa.clinica[@]ncfarma.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 298
• Est. completion date: February 28, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants of both sexes, aged 18 years or more;
• Participants with the diagnosis of Dyslipidemia presentinf low or intermediate cardiovascular risk, according to the Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
• Signed consent.

Exclusion Criteria:

• Diagnosis of familial hypercholesterolemia and other genetic diseases;
• Using medications that may interfere with the metabolism or serum levels of triglycerides;
• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
• Presence of concomitant cardiovascular disease, renal failure and hepatic Failure;
• Decompensated diabetes;
• Current smoking;
• History hypersensitivity to the active ingredients used in the study;
• Pregnancy or risk of pregnancy and lactating patients;
• History of alcohol abuse or illicit drug use;
• Participation in clinical trial in the year prior to this study.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertriglyceridemia

Intervention

Drug:
• Cipros 10 association
oral, once a day.
• Crestor 10 mg
oral, once a day.

Locations

Country	Name	City	State
Brazil	Allergisa	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of serum triglyceride levels measured between the first visit and last visit.		12 weeks
Secondary	Incidence and severity of adverse events recorded during the study.		13 weeks