HypertensionNCT06293261
Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia
An observational study of Hypertension and Hypercholesterolemia, run by Yuhan Corporation at 39 sites in South Korea.
Trial summary
This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Hypercholesterolemia
- What is being tested?
- Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg
- How many people
- 5,047 participants
- Where
- 39 sitesSouth Korea
- Study dates
- 27 Jun 2020to 31 Mar 2024
- How long will I take part?
- 12 Months
- 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
- Adult, Older adult
Study population: Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator
Who may be able to join
- Aged ≥ 19 years
- Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator
- Written informed consent
Who cannot join
- Patients with hypersensitivity to components of this drug or other dihydropyridine drugs
- A woman who is pregnant or likely to be pregnant, a woman of childbearing age who does not use appropriate contraception and a nursing woman
- a patient with severe liver failure
- Patients with active liver disease who include continuous serum transaminase elevation of unknown cause or serum transaminase elevation over three times the upper limit of normal
- a patient with severe aortic valvular stenosis
- a myopathy patient
- a cyclosporine co-administered patient
- a patient with severe renal failure (CLcr, creatinine clearance <30 mL/min)
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
South Korea39 sites
Hallym University Sacred Heart Hospital
Anyang-si
Dong-A University Hospital
Busan, 49201
Changwon Fatima Hospital
Changwon
Gyeongsang National University Changwon Hospital
Changwon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Yeungnam University Medical Center
Daegu
Daejeon Eulji Medical Center Eulji University
Daejeon
Myungji Hospital
Goyang-si
Chonnam National University Hospital
Gwangju
Chosun University Hospital
Gwangju
Bundang Jesaeng General Hospital
Gyeonggi-do
Cha University Bundang Medical Center
Gyeonggi-do
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do
Korea University Ansan Hospital
Gyeonggi-do
National Health Insurance Service Ilsan Hospital
Gyeonggi-do
Samsung Changwon Hospital
Gyeongsang
Wonkwang University Hospital
Iksan
Dongguk University Ilsan Hospital
Ilsan
Inje University Ilsan Paik Hospital
Ilsan
Inha University Hospital
Incheon
Kwandong University International St.Mary'S Hospital
Incheon
Soon Chun Hyang University Hospital Cheonan
Jungbuk
Dankook University Hospital
Jungnam
Kwangju Veterance Hospital
Kwangju
Pusan National University Hospital
Pusan
Pusan National University Yangsan Hospital
Pusan
Gangnam Severance Hospital
Seoul, 06273
Ewha Womans University Mokdong Hospital
Seoul
Ewha Womans University Seoul Hospital
Seoul
Hallym University Medical Center
Seoul
Kangdong Sacred Heart Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyung Hee University Medical Center
Seoul
National Medical Center
Seoul
Samsung Medical Center
Seoul
Ulsan University
Ulsan
Wonju Severance Christian Hospital
Wŏnju
About this study
This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia
Read the detailed description
All treatments, such as drug administration and clinical laboratory tests performed after Rosuampine administration, are performed according to the investigator's medical judgment, and information to be confirmed in this observational study is collected for up to 12 months.
- Conditions
- Hypertension, Hypercholesterolemia
- Being tested
- Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg
- Keywords
- long-term efficacy and safety of Rusuampin Tab
- Medical subject headings
- Hypertension, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mgDrug
Experimental only, not included active and placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg) | Not described Receives: Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg | |
| Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg) | Not described Receives: Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg | |
| Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg) | Not described Receives: Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg | |
| Rosuampin 10/10mg (Rosuvastatin | Not described Receives: Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)
Measured: Baseline, 12 Months
Secondary outcomes (5)
Change from baseline to 6/12 months in SBP and DBP
Measured: Baseline, 6, 12 Months
Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C)
Measured: Baseline, 6, 12 Months
Change from baseline to 6/12 months in hs-CRP
Measured: Baseline, 6, 12 Months
Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose)
Measured: Baseline, 6, 12 Months
Change from baseline to 6/12 months in Diabetes indicator ( HbA1c)
Measured: Baseline, 6, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start27 Jun 2020
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,047 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moohyun Kim, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293261
- Sponsor's protocol ID
- YMC043
- Status last verified
- Nov 2024
- First submitted
- 28 Feb 2024
- Last updated
- 22 Jan 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT06293261
- Acronym / sponsor ID
- YMC043
- Conditions
- Hypertension, Hypercholesterolemia
- Keywords
- long-term efficacy and safety of Rusuampin Tab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,047 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2020 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 5 Mar 2024 (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.
This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia
Detailed description
All treatments, such as drug administration and clinical laboratory tests performed after Rosuampine administration, are performed according to the investigator's medical judgment, and information to be confirmed in this observational study is collected for up to 12 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg) | – | Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg |
| Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg) | – | Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg |
| Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg) | – | Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg |
| Rosuampin 10/10mg (Rosuvastatin | – | Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator
Key inclusion criteria (3 listed)
- Aged ≥ 19 years
- Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator
- Written informed consent
Key exclusion criteria (8 listed)
- Patients with hypersensitivity to components of this drug or other dihydropyridine drugs
- A woman who is pregnant or likely to be pregnant, a woman of childbearing age who does not use appropriate contraception and a nursing woman
- a patient with severe liver failure
- Patients with active liver disease who include continuous serum transaminase elevation of unknown cause or serum transaminase elevation over three times the upper limit of normal
- a patient with severe aortic valvular stenosis
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 |
|---|---|---|
| Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mgExperimental only, not included active and placebo comparator | Drug | Rosuampin 10/10mg (Rosuvastatin, Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg), Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg), Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg) |
Primary outcome
Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)
Time frame: Baseline, 12 Months
5 secondary outcomes
Change from baseline to 6/12 months in SBP and DBP
Time frame: Baseline, 6, 12 Months
Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C)
Time frame: Baseline, 6, 12 Months
Change from baseline to 6/12 months in hs-CRP
Time frame: Baseline, 6, 12 Months
Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose)
Time frame: Baseline, 6, 12 Months
Change from baseline to 6/12 months in Diabetes indicator ( HbA1c)
Time frame: Baseline, 6, 12 Months
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 22 Jan 2025.
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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.
Moohyun Kim principal investigator
Dong-A University Hospital
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Hypercholesterolemia, run by Yuhan Corporation at 39 sites 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 8 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 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites 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?
Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) (time frame: Baseline, 12 Months). 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 22 Jan 2025.