Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia

January 21, 2025 updated by: Yuhan Corporation
This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5047

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang-si, Korea, Republic of
        • Hallym University Sacred Heart Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Changwon, Korea, Republic of
        • Changwon fatima hospital
      • Changwon, Korea, Republic of
        • Gyeongsang National University Changwon Hospital
      • Chungbuk, Korea, Republic of
        • Soon Chun Hyang University Hospital Cheonan
      • Chungnam, Korea, Republic of
        • Dankook University Hospital
      • Daegu, Korea, Republic of
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of
        • Yeungnam University Medical Center
      • Daejeon, Korea, Republic of
        • Daejeon Eulji Medical Center Eulji University
      • Goyang-si, Korea, Republic of
        • Myungji Hospital
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Gwangju, Korea, Republic of
        • Chosun University Hospital
      • Gyeonggi-do, Korea, Republic of
        • Korea University Ansan Hospital
      • Gyeonggi-do, Korea, Republic of
        • Hallym University Dongtan Sacred Heart Hospital
      • Gyeonggi-do, Korea, Republic of
        • CHA University Bundang Medical Center
      • Gyeonggi-do, Korea, Republic of
        • Bundang Jesaeng General Hospital
      • Gyeonggi-do, Korea, Republic of
        • National Health Insurance Service Ilsan Hospital
      • Gyeongsang, Korea, Republic of
        • Samsung Changwon Hospital
      • Iksan, Korea, Republic of
        • Wonkwang University Hospital
      • Ilsan, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Ilsan, Korea, Republic of
        • Dongguk University Ilsan Hospital
      • Incheon, Korea, Republic of
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Kwandong University International St.Mary'S Hospital
      • Kwangju, Korea, Republic of
        • Kwangju Veterance Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Yangsan Hospital
      • Seoul, Korea, Republic of
        • Ewha Womans University MokDong Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Kyung Hee University Medical Center
      • Seoul, Korea, Republic of
        • National medical center
      • Seoul, Korea, Republic of
        • Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Hallym University Medical Center
      • Seoul, Korea, Republic of
        • Ewha Womans University Seoul Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University
      • Wŏnju, Korea, Republic of
        • Wonju Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator

Description

Inclusion Criteria:

  1. Aged ≥ 19 years
  2. Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator
  3. Written informed consent

Exclusion Criteria:

  1. Patients with hypersensitivity to components of this drug or other dihydropyridine drugs
  2. 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
  3. a patient with severe liver failure
  4. 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
  5. a patient with severe aortic valvular stenosis
  6. a myopathy patient
  7. a cyclosporine co-administered patient
  8. a patient with severe renal failure (CLcr, creatinine clearance <30 mL/min)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg)
Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg
Experimental only, not included active and placebo comparator
Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg)
Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg
Experimental only, not included active and placebo comparator
Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg)
Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg
Experimental only, not included active and placebo comparator
Rosuampin 10/10mg (Rosuvastatin
Drug: Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg
Experimental only, not included active and placebo comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)
Time Frame: Baseline, 12 Months
Baseline, 12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline to 6/12 months in SBP and DBP
Time Frame: Baseline, 6, 12 Months
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
Baseline, 6, 12 Months
Change from baseline to 6/12 months in hs-CRP
Time Frame: Baseline, 6, 12 Months
Baseline, 6, 12 Months
Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose)
Time Frame: Baseline, 6, 12 Months
Baseline, 6, 12 Months
Change from baseline to 6/12 months in Diabetes indicator ( HbA1c)
Time Frame: Baseline, 6, 12 Months
Baseline, 6, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuhan Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Moohyun Kim, Dong-A University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YMC043

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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