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

E

EMS

Status and phase

Enrolling
Phase 3

Conditions

Hypertriglyceridemia
Dyslipidemia

Treatments

Drug: Crestor 10 mg
Drug: Cipros 10 association

Study type

Interventional

Funder types

Industry

Identifiers

NCT03527069
EMS0617-CIPROS

Details and patient eligibility

About

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

Enrollment

298 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

298 participants in 2 patient groups

CIPROS 10
Experimental group
Description:
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.
Treatment:
Drug: Cipros 10 association
Crestor
Active Comparator group
Description:
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.
Treatment:
Drug: Crestor 10 mg

Trial contacts and locations

1

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Central trial contact

Monalisa F.B. Oliveira, MD

Data sourced from clinicaltrials.gov

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