Dyslipidemia, Hypertension
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGOlmesartan Medoxomil
Olmesartan Medoxomil, Amoldipine Besylate, Rosuvastatin Ca
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. Adults over the age of 19 2. Patients eligible for Olomax Tab. prescription in accordance with the approved product manual in Korea 3. Patients who are determined to prescribe Olomax Tab. at the discretion of the investigators. * Antihypertensive agent: Do not include more than 3 agents. * Anti-abnormal lipidemia: Do not include more than 2 agents. * Subjects who are already administered beta blocker (BB) or diuretics due to other diseases such as angina, not for the purpose of treating hypertension may be included. 4. Consent on the use of information by the patient
Exclusion criteria
1. Patients who have already administered olomax tablets. 2. Subject who fall under ' Do not administer to the following patients' in the precautions for use 3. A patient who does not meet the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure treatment goal achievement rate | more than 24 weeks | 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 |
| LDL-C treatment goal achievement rate | more than 24 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the percentage of patients maintaining the treatment goal and the amount of change in blood pressure | 24 to 48 weeks | 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) |
| Patients who did not reach the treatment goal at baseline, change in blood pressure and rate of reaching the treatment goal | 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 at 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 | 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 at 24 to 48 weeks by antihypertensive drug (single, combined classification) |
| Change in LDL-C | 24 to 48 weeks | Change in LDL-C at 24 to 48 weeks compared to baseline |
| Among patients who reached the treatment goal at baseline, the change in LDL-C, 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 at 24 to 48 weeks and the proportion of patients maintaining the treatment goal |
| Among patients who reached the treatment goal at baseline, the change in LDL-C , the proportion of eligible patients maintaining the treatment goal | 24 to 48 weeks | 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 |
| Change in blood pressure | 24 to 48 weeks | Change in blood pressure at 24 to 48 weeks compared to baseline |
| Change amount and rate of change in lipid variables | 24 to 48 weeks | Change amount and rate of change in lipid variables (Non-HDL, HDL-C, TG, TC) at 24 to 48 weeks compared to the baseline |
| the rate and amount of change in both blood pressure and LDL-C | more than 24 weeks | 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 |
| Change in Framingham Risk Score (FRS) | more than 24 weeks | Change in Framingham Risk Score (FRS) over 24 weeks compared to baseline |
| change in carotid intima-media thickening (CIMT) value | more than 24 weeks | If data exists, change in carotid intima-media thickening (CIMT) value over 24 weeks compared to baseline |
| hsCRP change | more than 24 weeks | If information is collected, hsCRP change over 24 weeks compared to baseline |
| For patients who did not reach the treatment goal at baseline, change in LDL-C, rate of reaching the treatment goal | 24 to 48 weeks | 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 |
| The proportion of patients who have reached the treatment goal at baseline and maintain the change in blood pressure and treatment goal | 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 at 24 to 48 weeks |
Countries
South Korea
Outcome results
None listed