Evaluating Cipros 10 for treating high triglycerides and cholesterol levels
Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment
PHASE3 · EMS · NCT03527069
This study is testing if a new medication called Cipros 10 can help adults with high triglycerides and cholesterol levels feel better and reduce their heart risk when taken with Crestor.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 298 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | EMS (industry) |
| Locations | 1 site (Campinas, São Paulo) |
| Trial ID | NCT03527069 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of Cipros 10 in treating patients with isolated hypertriglyceridemia and dyslipidemia. Participants will receive Cipros 10 in combination with Crestor 10 mg, focusing on those with low to intermediate cardiovascular risk. The study will include adults aged 18 and older who meet specific inclusion criteria while excluding those with certain health conditions or medication interactions. The trial is designed to provide insights into the effectiveness of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with dyslipidemia and classified as having low or intermediate cardiovascular risk.
Not a fit: Patients with familial hypercholesterolemia, significant cardiovascular disease, or those on conflicting medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve lipid profiles and reduce cardiovascular risk for patients with dyslipidemia.
How similar studies have performed: Previous studies have shown promise in treating dyslipidemia with similar pharmacological approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Campinas, São Paulo
- Allergisa — Campinas, São Paulo, Brazil (RECRUITING)
Study contacts
- Study coordinator: Monalisa F.B. Oliveira, MD
- Email: pesquisa.clinica@ncfarma.com.br
- Phone: +551938879851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertriglyceridemia, Dyslipidemia