Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment

February 23, 2023 updated by: EMS

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

312

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
        • Recruiting
        • 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

Genders Eligible for Study

All

Description

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.

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 20

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
oral, once a day
Other Names:
  • EMS Association
Active Comparator: Crestor

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
Oral, once a day
Other Names:
  • Rosuvastatin 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks vs baseline
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.
12 weeks vs baseline

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 (Anticipated)

November 30, 2023

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 28, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 23, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS0717

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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