Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment (CIPROS20)

EMS

Status and phase: Completed; Phase 3

Conditions: Dyslipidemias

Treatments: Drug: Cipros 20 association; Drug: Crestor 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03540355

EMS0717

Details and patient eligibility

About

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

Enrollment: 406 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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406 participants in 2 patient groups

Cipros 20

Experimental group

Description:

The study is double-masked, the patient will take 2 tablets, as follow: 1 tablet Cipros 20 association; and 1 tablet crestor placebo. Oral, once a day

Treatment:

Drug: Cipros 20 association

Crestor

Active Comparator group

Description:

The study is double-masked, the patient will take 2 tablets, as follow: 1 tablet Crestor 20 mg; and 1 tablet cipros association placebo. Oral, once a day

Treatment:

Drug: Crestor 20 mg