HypertriglyceridemiaPhase 3NCT03527069
Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment
A Phase 3 study testing Cipros 10 association and Crestor 10 mg in people with Hypertriglyceridemia and Dyslipidemia, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertriglyceridemia, Dyslipidemia
- What is being tested?
- Cipros 10 association and Crestor 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Jan 2021to 25 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment
The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment
- Conditions
- Hypertriglyceridemia, Dyslipidemia
- Being tested
- Cipros 10 association, Crestor 10 mg
- Medical subject headings
- Hypertriglyceridemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cipros 10 associationDrug
Also called EMS association
oral, once a day.
Crestor 10 mgDrug
Also called Rosuvastatin 10 mg
oral, once a day.
| Study group | Role | What they receive |
|---|---|---|
| CIPROS 10 | Experimental | 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. Receives: Drug: Cipros 10 association |
| Crestor | Active comparator | 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. Receives: Drug: Crestor 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of serum triglyceride levels measured between the first visit and last visit.
Measured: 12 weeks
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start29 Jan 2021
- Primary completion30 Aug 2024
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527069
- Sponsor's protocol ID
- EMS0617-CIPROS
- Status last verified
- Dec 2025
- First submitted
- 4 May 2018
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment
- ClinicalTrials.gov ID
- NCT03527069
- Acronym / sponsor ID
- EMS0617-CIPROS
- Conditions
- Hypertriglyceridemia, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIPROS 10 | Experimental | Drug: Cipros 10 associationThe 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. |
| Crestor | Active comparator | Drug: Crestor 10 mgThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cipros 10 associationAlso: EMS associationoral, once a day. | Drug | CIPROS 10 |
| Crestor 10 mgAlso: Rosuvastatin 10 mgoral, once a day. | Drug | Crestor |
Primary outcome
Reduction of serum triglyceride levels measured between the first visit and last visit.
Time frame: 12 weeks
1 secondary outcome
Incidence and severity of adverse events recorded during the study.
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
Related trials for Hypertriglyceridemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
RecruitingPhase 2
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Hypertriglyceridemia, Severe Hypertriglyceridemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cipros 10 association and Crestor 10 mg in people with Hypertriglyceridemia and Dyslipidemia, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of serum triglyceride levels measured between the first visit and last visit. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.