Dyslipidemias, Hypertension
Conditions
Brief summary
This study is a large-scale, prospective, multi-center, and non-interventional observation study to observe blood pressure and blood lipid changes and safety during administration of olomax tablets for 24 weeks in hypertensive patients with dyslipidemia.
Detailed description
In this study, investigator will evaluate subjects' clinical performance in actual care. Laboratory test results such as demographic information and medical treatment, blood pressure, blood lipid test, and liver function test conducted at the start date of Olomax tablet administration and subsequent 24 weeks (± 8 weeks) will be collected. In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.
Interventions
DRUGOlmesartan Medoxomil/ Amlodipine Besylate/ Rosuvastatin Ca
Olomax Tab 20/5/5mg Olomax Tab 20/5/10mg Olomax Tab 40/5/5mg Olomax Tab 40/5/10mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult aged 19 or older at the time of the baseline visit. 2. A patient with hypertension and dyslipidemia who is scheduled to administer olomax tablet according to investigator's medical judgement. * Patients who were previously taking more than two tablets of a single drug, low-density lipoprotein-cholesterol (LDL-C) * Patients who were previously only taking blood pressure-lowering drugs and did not take LDL-C-lowering drugs, but who need to take additional LDL-C-lowering drugs at the discretion of the researcher * Patients who were previously taking LDL-C lowering agents and did not take blood pressure lowering agents, but who need to take additional blood pressure lowering agents according to the researcher's judgment * Patients who have not previously taken both a blood pressure drop and an LDL-C drop but need additional simultaneous use at the discretion of the researcher 3. A person who can understand the information provided to him/her and may voluntarily sign a written consent form
Exclusion criteria
1. A person who falls under the prohibition of administration according to the permission for olomax tablet 2. A person who has a history of administering olomax tablets before participating in this study 3. In addition to the above, a person that the investigator thinks he/she is not suitable for participating in this observation study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of change in LDL-C | at 24 weeks | The rate of change in LDL-C at 12 weeks from baseline |
| The amount of change in LDL-C | at 24 weeks | The amount of change in LDL-C at 24 weeks from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of change in SBP(Systolic Blood Pressure) | 12 weeks | The rate of change in SBP(Systolic Blood Pressure) at 12 weeks from baseline |
| The amount of change in SBP(Systolic Blood Pressure) | 12 weeks | The amount of change in SBP(Systolic Blood Pressure) at 12 weeks from baseline |
| The rate of change in LDL-C | at 12 weeks | The rate of change in LDL-C at 12 weeks from baseline |
| The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG) | 12 weeks | The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 12 weeks from baseline |
| Percentage of subjects who reached LDL-C target | 12 weeks | Percentage of subjects who reached LDL-C target according to Korean Society of Lipid/Arteriosclerosis's risk classification in the guidelines for the treatment of dyslipidemia (2018) at 12 weeks from baseline |
| The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG) | 12 weeks | The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG) at 12 weeks from baseline |
| The amount of change in LDL-C | at 12 weeks | The amount of change in LDL-C at 12 weeks from baseline |
Countries
South Korea
Outcome results
None listed