Cardiovascular DiseasesFIMARONCT02913794
Fimasartan and Rosuvastatin for Hypertension and Dyslipidemia Control
An observational study of Cardiovascular Diseases and Hyperlipidemias, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
Fimasartan and Rosuvastatin for hypertension and dyslipidemia control Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiovascular Diseases, Hyperlipidemias
- How many people
- 541 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2016to 29 Mar 2018
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1,056 patients
Who may be able to join
- Hypertension patients who are taking an anti-hypertensive agent, including Fimasartan at least 12 weeks or more.
- Dyslipidemia patients who are taking dyslipidemia drug, including Rosuvastatin at least 12 weeks or more
- Patients who has blood pressure and lipid levels (Total cholesterol, LDL-C, HDL-C, non-HDL-C, * TG) checks 2 weeks before registration
Who cannot join
- Patients being hospitalized
- Patients who stop taking Fimasartan or Rosuvastatin within 12 weeks 14 or more consecutive days
- Patients who have more than 400mg/dl triglyceride(TG) at the registration time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Cross-sectional Study to Evaluate the Effectiveness of Antihypertensive Treatment Including Fimasartan and the Dyslipidemia Treatment Including Rosuvastatin and to Assess the Association Between the Two Treatments
Fimasartan and Rosuvastatin for hypertension and dyslipidemia control
- Conditions
- Cardiovascular Diseases, Hyperlipidemias
- Medical subject headings
- Cardiovascular Diseases, Hyperlipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-relation between blood pressure and dyslipidemia
Check the blood pressure and dyslipidemia control rates, also check the correlation between these two disease
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start11 Oct 2016
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyung-Jin Jung, Study director, Boryung Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913794
- Sponsor's protocol ID
- BR-FMS-OS-402
- Acronym
- FIMARO
- Status last verified
- Jun 2023
- First submitted
- 21 Sep 2016
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Cross-sectional Study to Evaluate the Effectiveness of Antihypertensive Treatment Including Fimasartan and the Dyslipidemia Treatment Including Rosuvastatin and to Assess the Association Between the Two Treatments
- ClinicalTrials.gov ID
- NCT02913794
- Acronym / sponsor ID
- FIMARO / BR-FMS-OS-402
- Conditions
- Cardiovascular Diseases, Hyperlipidemias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 26 Sep 2016 (estimated)
- 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.
Fimasartan and Rosuvastatin for hypertension and dyslipidemia control
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1,056 patients
Key inclusion criteria (3 listed)
- Hypertension patients who are taking an anti-hypertensive agent, including Fimasartan at least 12 weeks or more.
- Dyslipidemia patients who are taking dyslipidemia drug, including Rosuvastatin at least 12 weeks or more
- Patients who has blood pressure and lipid levels (Total cholesterol, LDL-C, HDL-C, non-HDL-C, * TG) checks 2 weeks before registration
Key exclusion criteria (3 listed)
- Patients being hospitalized
- Patients who stop taking Fimasartan or Rosuvastatin within 12 weeks 14 or more consecutive days
- Patients who have more than 400mg/dl triglyceride(TG) at the registration time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Co-relation between blood pressure and dyslipidemia
Time frame: 12 weeks
Check the blood pressure and dyslipidemia control rates, also check the correlation between these two disease
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 12 Jun 2023.
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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.
Hyung-Jin Jung study director
Boryung Pharmaceutical Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Hyperlipidemias, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
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 3 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 12 Jun 2023. 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 South Korea. 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.
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?
Co-relation between blood pressure and dyslipidemia (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 12 Jun 2023.