Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment
CIPROS20
Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 20 Association on the Dyslipidemia Treatment
1 other identifier
interventional
406
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of Cipros 20 association in the treatment of dyslipidemia treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2021
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedStudy Start
First participant enrolled
March 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2025
CompletedJanuary 9, 2026
January 1, 2026
3.9 years
May 15, 2018
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Reduction of serum triglyceride levels
The reduction of triglyceride levels will be measured through the difference of values in the first visit and last visit.
12 weeks vs baseline
Reduction of serum LDL-c
The reduction of serum-LDL-c will be measured through the difference of values in the first and last visit.
12 weeks vs baseline
Secondary Outcomes (1)
Incidence and severity of adverse events recorded during the study
13 weeks
Study Arms (2)
Cipros 20
EXPERIMENTALThe study is double-masked, the patient will take 2 tablets, as follow: 1 tablet Cipros 20 association; and 1 tablet crestor placebo. Oral, once a day
Crestor
ACTIVE COMPARATORThe study is double-masked, the patient will take 2 tablets, as follow: 1 tablet Crestor 20 mg; and 1 tablet cipros association placebo. Oral, once a day
Interventions
Eligibility Criteria
You may qualify if:
- Participants of both sexes, aged 18 years or more;
- Participants with the diagnosed of dyslipidemia and with high or very high cardiovascular risk, according to the Brazillian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- Signed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMSlead
Study Sites (1)
Allergisa
Campinas, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2018
First Posted
May 30, 2018
Study Start
March 2, 2021
Primary Completion
January 23, 2025
Study Completion
January 23, 2025
Last Updated
January 9, 2026
Record last verified: 2026-01