Dyslipidemia, Hypertriglyceridemia
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment
Interventions
DRUGCipros 10 association
oral, once a day.
DRUGCrestor 10 mg
oral, once a day.
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of serum triglyceride levels measured between the first visit and last visit. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events recorded during the study. | 13 weeks |
Countries
Brazil
Outcome results
None listed