Back to resultsEfficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment
Primary Purpose
Dyslipidemias
Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Cipros 20 association
Crestor 20 mg
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- AllergisaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cipros 20
Crestor
Arm Description
The 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
The 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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Incidence and severity of adverse events recorded during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03540355
Brief Title
Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment
Official Title
Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 20 Association on the Dyslipidemia Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of Cipros 20 association in the treatment of dyslipidemia treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
312 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cipros 20
Arm Type
Experimental
Arm Description
The 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
Arm Title
Crestor
Arm Type
Active Comparator
Arm Description
The 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
Intervention Type
Drug
Intervention Name(s)
Cipros 20 association
Other Intervention Name(s)
EMS Association
Intervention Description
oral, once a day
Intervention Type
Drug
Intervention Name(s)
Crestor 20 mg
Other Intervention Name(s)
Rosuvastatin 20 mg
Intervention Description
Oral, once a day
Primary Outcome Measure Information:
Title
Reduction of serum triglyceride levels
Description
The reduction of triglyceride levels will be measured through the difference of values in the first visit and last visit.
Time Frame
12 weeks vs baseline
Title
Reduction of serum LDL-c
Description
The reduction of serum-LDL-c will be measured through the difference of values in the first and last visit.
Time Frame
12 weeks vs baseline
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events recorded during the study
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monalisa F.B Oliveira, M.D.
Phone
+55193887-9851
Email
pesquisa.clinica@ems.com.br
Facility Information:
Facility Name
Allergisa
City
Campinas
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro A Crippa, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment
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