Clinical trial
Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment
Name
EMS0617-CIPROS
Description
The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment
Trial arms
Trial start
2021-01-29
Estimated PCD
2024-06-30
Trial end
2025-02-28
Status
Recruiting
Phase
Early phase I
Treatment
Cipros 10 association
oral, once a day.
Arms:
CIPROS 10
Other names:
EMS association
Crestor 10 mg
oral, once a day.
Arms:
Crestor
Other names:
Rosuvastatin 10 mg
Size
298
Primary endpoint
Reduction of serum triglyceride levels measured between the first visit and last visit.
12 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 298, 'type': 'ESTIMATED'}}
Updated at
2024-02-16
1 organization
2 products
2 indications
Organization
EMSProduct
Cipros 10Indication
HypertriglyceridemiaIndication
lipid metabolism disorderProduct
Crestor