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Throughout this study, the efficacy and safety information of Olomax tablets will be collected from 24 weeks to 48 weeks(+8 weeks) The Data collection point is baseline, at more than 24 weeks, at more than 48 weeks(+8 weeks).
The study will start after investigator determines the administration of Olomax tablets based on the investigator's judgement and obtaining informed consent from the subject during subject's daily visit.
The dose of the Olomax tablet for each subject will be determined based on efficacy and drug resistance according to the subject's previous drug administration.
Throughout this study, the efficacy and safety information of Olomax tablets will be collected from 24 weeks to 48 weeks(+8 weeks) The Data collection point is baseline, at more than 24 weeks, at more than 48 weeks(+8 weeks).
Efficacy of Olomax tablets will be evaluated based on the data collected from more than 24 weeks to 48 weeks(+8 weeks) from the baseline visit. Safety of Olomax tablets will be evaluated based on the adverse events collected during the study peroid.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olmesartan Medoxomil | Drug | Olmesartan Medoxomil, Amoldipine Besylate, Rosuvastatin Ca |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure treatment goal achievement rate | Blood pressure treatment goal achievement rate: The percentage of patients observed for more than 24 weeks compared to the baseline whose blood pressure reached the target value | more than 24 weeks |
| LDL-C treatment goal achievement rate | LDL-C treatment goal achievement rate: The percentage of patients observed for more than 24 weeks compared to the baseline whose LDL-C reached the target level | more than 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Change in blood pressure at 24 to 48 weeks compared to baseline | 24 to 48 weeks |
| The proportion of patients who have reached the treatment goal at baseline and maintain the change in blood pressure and treatment goal |
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Inclusion Criteria:
Adults over the age of 19
Patients eligible for Olomax Tab. prescription in accordance with the approved product manual in Korea
Patients who are determined to prescribe Olomax Tab. at the discretion of the investigators.
Consent on the use of information by the patient
Exclusion Criteria:
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The number of patients was calculated based on the analysis results of the blood pressure treatment goal achievement rate and LDL-C treatment goal acheivement rate in the Olomax Tertiary Clinical Trial.
n=(〖Z_(α/2)〗^2×p(1-p))/d^2
:: Type 1 error (=0.05) p: Target Reach Rate at 24+ Weeks (=80%) d: Sampling error
herefore, it means that the total number of patients required to be 95% confident that the proportion of patients whose two primary evaluation variables, blood pressure and LDL, will be included in 79-81%. Considering the dropout rate of about 20%, a total of 7,684 patients are required, so in this study, approximately 8,000 patients approximating this are finally recruited.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | Gyeonggi-do | 18450 | South Korea |
Undecided
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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The proportion of patients who have reached the treatment goal at baseline and maintain the change in blood pressure and treatment goal at 24 to 48 weeks
| 24 to 48 weeks |
| the percentage of patients maintaining the treatment goal and the amount of change in blood pressure | Among patients who reached the treatment goal at baseline, the percentage of patients maintaining the treatment goal and the amount of change in blood pressure at 24 to 48 weeks for each antihypertensive drug (single, double drug combination classification) | 24 to 48 weeks |
| Patients who did not reach the treatment goal at baseline, change in blood pressure and rate of reaching the treatment goal | Patients who did not reach the treatment goal at baseline, change in blood pressure and rate of reaching the treatment goal at 24 to 48 weeks | 24 to 48 weeks |
| For patients who did not reach the treatment goal at baseline, the amount of change in blood pressure and the rate of reaching the treatment goal | For patients who did not reach the treatment goal at baseline, the amount of change in blood pressure and the rate of reaching the treatment goal at 24 to 48 weeks by antihypertensive drug (single, combined classification) | 24 to 48 weeks |
| Change in LDL-C | Change in LDL-C at 24 to 48 weeks compared to baseline | 24 to 48 weeks |
| Among patients who reached the treatment goal at baseline, the change in LDL-C, the proportion of patients maintaining the treatment goal | Among patients who reached the treatment goal at baseline, the change in LDL-C at 24 to 48 weeks and the proportion of patients maintaining the treatment goal | 24 to 48 weeks |
| Among patients who reached the treatment goal at baseline, the change in LDL-C , the proportion of eligible patients maintaining the treatment goal | Among patients who reached the treatment goal at baseline, the change in LDL-C at 24 to 48 weeks for each anti-dyslipidemia agent and the proportion of eligible patients maintaining the treatment goal | 24 to 48 weeks |
| For patients who did not reach the treatment goal at baseline, change in LDL-C, rate of reaching the treatment goal | For patients who did not reach the treatment goal at baseline, change in LDL-C and rate of reaching the treatment goal at 24 to 48 weeks | 24 to 48 weeks |
| For patients who did not reach the treatment goal at baseline, change in LDL-C, rate of reaching the treatment goal | For patients who did not reach the treatment goal at baseline, change in LDL-C and rate of reaching the treatment goal at 24 to 48 weeks for each anti-dyslipidemia agent | 24 to 48 weeks |
| Change amount and rate of change in lipid variables | Change amount and rate of change in lipid variables (Non-HDL, HDL-C, TG, TC) at 24 to 48 weeks compared to the baseline | 24 to 48 weeks |
| the rate and amount of change in both blood pressure and LDL-C | Patients who underwent FU for more than 24 weeks compared to the baseline, the rate and amount of change in both blood pressure and LDL-C reached the target values | more than 24 weeks |
| Change in Framingham Risk Score (FRS) | Change in Framingham Risk Score (FRS) over 24 weeks compared to baseline | more than 24 weeks |
| change in carotid intima-media thickening (CIMT) value | If data exists, change in carotid intima-media thickening (CIMT) value over 24 weeks compared to baseline | more than 24 weeks |
| hsCRP change | If information is collected, hsCRP change over 24 weeks compared to baseline | more than 24 weeks |
| D009750 | Nutritional and Metabolic Diseases |
| D013777 |
| Tetrazoles |