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Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03540355
Recruitment Status : Not yet recruiting
First Posted : May 30, 2018
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
EMS

Brief Summary:
The purpose of this study is to evaluate the efficacy of Cipros 20 association in the treatment of dyslipidemia treatment.

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: Cipros 20 association Drug: Crestor 20 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 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 20 Association on the Dyslipidemia Treatment
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cipros 20

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

Drug: Cipros 20 association
oral, once a day
Other Name: EMS Association

Active Comparator: Crestor

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

Drug: Crestor 20 mg
Oral, once a day
Other Name: Rosuvastatin 20 mg




Primary Outcome Measures :
  1. Reduction of serum triglyceride levels [ Time Frame: 12 weeks vs baseline ]
    The reduction of triglyceride levels will be measured through the difference of values in the first visit and last visit.

  2. Reduction of serum LDL-c [ Time Frame: 12 weeks vs baseline ]
    The reduction of serum-LDL-c will be measured through the difference of values in the first and last visit.


Secondary Outcome Measures :
  1. Incidence and severity of adverse events recorded during the study [ Time Frame: 13 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540355


Contacts
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Contact: Monalisa F.B Oliveira, M.D. +55193887-9851 pesquisa.clinica@ems.com.br

Sponsors and Collaborators
EMS

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT03540355    
Other Study ID Numbers: EMS0717
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ciprofloxacin
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors