CClinicalTrials.gg
Sign In
CompletedNCT03527069Updated Dec 8, 2025

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

A Phase 3 interventional study of Cipros 10 association and Crestor 10 mg in Hypertriglyceridemia and Dyslipidemia, sponsored by EMS. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by EMS · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypertriglyceridemia
  • Dyslipidemia
03

In context

Hypertriglyceridemia

296 studies on the registry are indexed under Hypertriglyceridemia; 39 are open to participants now.

This study's enrollment of 146 is above the median of 66 across 259 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
146 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugCipros 10 association

    oral, once a day.

    Also known as: EMS association

  • DrugCrestor 10 mg

    oral, once a day.

    Also known as: Rosuvastatin 10 mg

06

What researchers measure

Primary outcomes

  1. Reduction of serum triglyceride levels measured between the first visit and last visit.

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 13 weeks

07

Study locations

1 site
  • Allergisa
    Campinas, São Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03527069
Lead sponsor
EMS
Responsible party
Sponsor
First posted
May 16, 2018
Start date
Jan 29, 2021
Primary completion
Aug 30, 2024
Completion
Jul 25, 2025
Last update
Dec 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertriglyceridemia→

Other studies from this sponsor

EMS

Start the discussion