Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment

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

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

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: Cipros 20 association
* Drug: Crestor 20 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cipros 20<br>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 | Drug: Cipros 20 association<br>* oral, once a day<br>* Other names: EMS Association;|
| Active Comparator: Crestor<br>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 | Drug: Crestor 20 mg<br>* Oral, once a day<br>* Other names: Rosuvastatin 20 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study |  | 13 weeks |