Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment

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



Sponsors

Lead Sponsor

 EMS


Source

EMS

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

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

Overall Status

Not yet recruiting

Start Date

2018-10-01

Completion Date

2020-01-30

Primary Completion Date

2019-09-30

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure

Time Frame

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

Secondary Outcome

Measure

Time Frame

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

Enrollment

298

Conditions


Intervention

Intervention Type

Drug

Intervention Name


Description

oral, once a day.

Arm Group Label

CIPROS 10

Other Name

EMS association


Intervention Type

Drug

Intervention Name


Description

oral, once a day.

Arm Group Label

Crestor

Other Name

Rosuvastatin 10 mg



Eligibility

Criteria

Inclusion Criteria:

- Participants of both sexes, aged 18 years or more;

- Participants with the diagnosed of Isolated Hypertriglyceridemia and Dyslipidemia,
according to the Brazilian Guidelines on Dyslipidemia and Prevention of
Atherosclerosis;

- Agree to maintain healthy lifestyle during the protocol;

- Signed consent.

Exclusion Criteria:

- Diagnosis of other dyslipidemia according the Brazilian Guidelines on Dyslipidemia and
Prevention of Atherosclerosis;

- 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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Contact

Last Name

Monalisa F.B. Oliveira, MD

Phone

+551938879851

Email



Verification Date

2018-05-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Intervention Browse

Mesh Term

Rosuvastatin Calcium

Ciprofloxacin



Arm Group

Arm Group Label

CIPROS 10

Arm Group Type

Experimental

Description

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.


Arm Group Label

Crestor

Arm Group Type

Active Comparator

Description

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.



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Double (Participant, Investigator)


Study First Submitted

May 4, 2018

Study First Submitted Qc

May 4, 2018

Study First Posted

May 16, 2018

Last Update Submitted

May 4, 2018

Last Update Submitted Qc

May 4, 2018

Last Update Posted

May 16, 2018


ClinicalTrials.gov processed this data on May 16, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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