DyslipidemiasPhase 3CIPROS20NCT03540355
Efficacy and Safety of Cipros 20 Association on Dyslipidemia Treatment
A Phase 3 study testing Cipros 20 association and Crestor 20 mg in people with Dyslipidemias, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of Cipros 20 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
- Dyslipidemias
- What is being tested?
- Cipros 20 association and Crestor 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Mar 2021to 23 Jan 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 diagnosed of dyslipidemia and with high or very high cardiovascular risk, according to the Brazillian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- Signed consent.
Who cannot join
- 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;
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- 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 20 Association on the Dyslipidemia Treatment
The purpose of this study is to evaluate the efficacy of Cipros 20 association in the treatment of dyslipidemia treatment.
- Conditions
- Dyslipidemias
- Being tested
- Cipros 20 association, Crestor 20 mg
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cipros 20 associationDrug
Also called EMS Association
oral, once a day
Crestor 20 mgDrug
Also called Rosuvastatin 20 mg
Oral, once a day
| Study group | Role | What they receive |
|---|---|---|
| Cipros 20 | Experimental | 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 Receives: Drug: Cipros 20 association |
| Crestor | Active comparator | 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 Receives: Drug: Crestor 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of serum triglyceride levels
The reduction of triglyceride levels will be measured through the difference of values in the first visit and last visit.
Measured: 12 weeks vs baseline
Reduction of serum LDL-c
The reduction of serum-LDL-c will be measured through the difference of values in the first and last visit.
Measured: 12 weeks vs baseline
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 posted30 May 2018
- Study start2 Mar 2021
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540355
- Sponsor's protocol ID
- EMS0717
- Acronym
- CIPROS20
- Status last verified
- Jan 2026
- First submitted
- 15 May 2018
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. 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 20 Association on the Dyslipidemia Treatment
- ClinicalTrials.gov ID
- NCT03540355
- Acronym / sponsor ID
- CIPROS20 / EMS0717
- Conditions
- Dyslipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 30 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 20 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 20 | Experimental | Drug: Cipros 20 associationThe 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 |
| Crestor | Active comparator | Drug: Crestor 20 mgThe 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 |
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 diagnosed of dyslipidemia and with high or very high cardiovascular risk, according to the Brazillian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
- Signed consent.
Key exclusion criteria (9 listed)
- 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;
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 20 associationAlso: EMS Associationoral, once a day | Drug | Cipros 20 |
| Crestor 20 mgAlso: Rosuvastatin 20 mgOral, once a day | Drug | Crestor |
Primary outcome
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.
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.
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 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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 20 association and Crestor 20 mg in people with Dyslipidemias, 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 9 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 9 Jan 2026. 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 (time frame: 12 weeks vs baseline). The study lists 2 primary outcomes in all. 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 9 Jan 2026.