Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment

December 1, 2025 updated by: EMS

Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment

The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil
        • Allergisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants of both sexes, aged 18 years or more;
  • Participants with the diagnosis of Dyslipidemia presentinf low or intermediate cardiovascular risk, according to the Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
  • Signed consent.

Exclusion Criteria:

  • Diagnosis of familial hypercholesterolemia and other genetic diseases;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CIPROS 10

The study is double-Masked, the patient wil take 2 tablets, as follow:

1 tablet Cipros 10 association; and

1 tablet crestor placebo Oral, once a day.
Drug: Cipros 10 association
oral, once a day.
Other Names:
  • EMS association
Active Comparator: Crestor

The study is double-Masked, the patient wil take 2 tablets, as follow:

1 tablet Crestor 10mg; and

1 tablet Cipros association placebo Oral, once a day.
Drug: Crestor 10 mg
oral, once a day.
Other Names:
  • Rosuvastatin 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of serum triglyceride levels measured between the first visit and last visit.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events recorded during the study.
Time Frame: 13 weeks
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2021

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

July 25, 2025

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS0617-CIPROS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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