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Completed

NCT Number: NCT03540355

Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment

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

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allergisa

Campinas, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cipros 20 association

Drug

oral, once a day

Other names: EMS Association

Crestor 20 mg

Drug

Oral, once a day

Other names: Rosuvastatin 20 mg

Primary outcomes

  1. Reduction of serum triglyceride levels

    Time frame: 12 weeks vs baseline

    The reduction of triglyceride levels will be measured through the difference of values in the first visit and last visit.

  2. Reduction of serum LDL-c

    Time frame: 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 outcomes

  1. Incidence and severity of adverse events recorded during the study

    Time frame: 13 weeks

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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

Acronym: CIPROS20

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 30, 2018
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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