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Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and 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: NCT03527069
Recruitment Status : Not yet recruiting
First Posted : May 16, 2018
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
EMS

Study Description
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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
Hypertriglyceridemia Dyslipidemia Drug: Cipros 10 association Drug: Crestor 10 mg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 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

MedlinePlus related topics: Triglycerides

Arms and Interventions
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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 Name: 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 Name: Rosuvastatin 10 mg


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of serum triglyceride levels measured between the first visit and last visit. [ Time Frame: 12 weeks ]

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

Eligibility Criteria
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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 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
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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): NCT03527069


Contacts
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Contact: Monalisa F.B. Oliveira, MD +551938879851 pesquisa.clinica@ncfarma.com.br

Sponsors and Collaborators
EMS
More Information
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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT03527069    
Other Study ID Numbers: EMS0617-CIPROS
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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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
Hypertriglyceridemia
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Rosuvastatin Calcium
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors