Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03540355

Acronym

CIPROS20

Enrollment

406

Registered

2018-05-30

Start date

2021-03-02

Completion date

2025-01-23

Last updated

2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias

Brief summary

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

Interventions

DRUGCipros 20 association

oral, once a day

DRUGCrestor 20 mg

Oral, once a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Reduction of serum triglyceride levels	12 weeks vs baseline	The reduction of triglyceride levels will be measured through the difference of values in the first visit and last visit.
Reduction of serum LDL-c	12 weeks vs baseline	The reduction of serum-LDL-c will be measured through the difference of values in the first and last visit.

Secondary

Measure	Time frame
Incidence and severity of adverse events recorded during the study	13 weeks

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026