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

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: Recruiting
• Conditions: Dyslipidemia; Hypertriglyceridemia
• Intervention / Treatment: Drug: Cipros 10 association; Drug: Crestor 10 mg

• Study Type: Interventional
• Enrollment (Estimated): 298
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Monalisa F.B. Oliveira, MD; Phone Number: +551938879851; Email: pesquisa.clinica@ncfarma.com.br

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil
      • Recruiting
      • Allergisa
      • Contact: Mauro A Crippa, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): February 28, 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): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• 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