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Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment

Sponsor
EMS (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03527069
Collaborator
(none)
298
Enrollment
1
Location
2
Arms
37
Anticipated Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment

Condition or Disease Intervention/Treatment Phase
  • Drug: Cipros 10 association
  • Drug: Crestor 10 mg
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
298 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment
Actual Study Start Date :
Jan 29, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CIPROS 10

The study is double-Masked, the patient wil take 2 tablets, as follow: 1 tablet Cipros 10 association; and 1 tablet crestor placebo Oral, once a day.

Drug: Cipros 10 association
oral, once a day.
Other Names:
  • EMS association

    		•
    Active Comparator: Crestor

    The study is double-Masked, the patient wil take 2 tablets, as follow: 1 tablet Crestor 10mg; and 1 tablet Cipros association placebo Oral, once a day.

    Drug: Crestor 10 mg
    oral, once a day.
    Other Names:
  • Rosuvastatin 10 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction of serum triglyceride levels measured between the first visit and last visit. [12 weeks]

    Secondary Outcome Measures

    1. Incidence and severity of adverse events recorded during the study. [13 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Allergisa Campinas São Paulo Brazil

    Sponsors and Collaborators

    • EMS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    EMS
    ClinicalTrials.gov Identifier:
    NCT03527069
    Other Study ID Numbers:
    • EMS0617-CIPROS
    First Posted:
    May 16, 2018
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dyslipidemias
    Hypertriglyceridemia
    Rosuvastatin Calcium

    Study Results

    No Results Posted as of Aug 5, 2022