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

NCT03527069 | Completed Phase 3

• 1 other identifier: EMS0617-CIPROS
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertriglyceridemia; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (1)

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

  13 weeks

Study Arms (2)

CIPROS 10

EXPERIMENTAL

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

Crestor

ACTIVE COMPARATOR

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

Cipros 10 association DRUG

oral, once a day.

Also known as: EMS association

CIPROS 10

Crestor 10 mg DRUG

oral, once a day.

Also known as: Rosuvastatin 10 mg

Crestor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Allergisa

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Hypertriglyceridemia; Dyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 16, 2018
• Study Start: January 29, 2021
• Primary Completion: August 30, 2024
• Study Completion: July 25, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

BR (1)