Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment

Dyslipidemias Clinical Trial

Official title:

Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 20 Association on the Dyslipidemia Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03540355
• Other study ID #: EMS0717
• Status: Recruiting
• Phase: Phase 3
• Start date: January 29, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2023
• Source: EMS
• Contact: Monalisa F.B Oliveira, M.D.
• Phone: +55193887-9851
• Email: pesquisa.clinica[@]ems.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Cipros 20 association in the treatment of dyslipidemia treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: February 28, 2024
• Est. primary completion date: November 30, 2023
• 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 diagnosed of dyslipidemia and with high or very high cardiovascular risk, according to the Brazillian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;

• Signed consent.

Exclusion Criteria:

• 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

• Dyslipidemias

Intervention

Drug:
• Cipros 20 association
oral, once a day
• Crestor 20 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	The reduction of triglyceride levels will be measured through the difference of values in the first visit and last visit.	12 weeks vs baseline
Primary	Reduction of serum LDL-c	The reduction of serum-LDL-c will be measured through the difference of values in the first and last visit.	12 weeks vs baseline
Secondary	Incidence and severity of adverse events recorded during the study		13 weeks