An observational study in Hypertension and Dyslipidemia, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by Daewoong Pharmaceutical Co. LTD. · Observational
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 5,450 is above the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Patients who are determined to prescribe Olomax Tab. at the discretion of the investigators.
Exclusion Criteria:
Olmesartan Medoxomil, Amoldipine Besylate, Rosuvastatin Ca
Also known as: Amoldipine Besylate, Rosuvastatin Ca
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
Time frame: 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
Time frame: more than 24 weeks
Change in blood pressure
Change in blood pressure at 24 to 48 weeks compared to baseline
Time frame: 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
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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 24 to 48 weeks
Change in LDL-C
Change in LDL-C at 24 to 48 weeks compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: more than 24 weeks
Change in Framingham Risk Score (FRS)
Change in Framingham Risk Score (FRS) over 24 weeks compared to baseline
Time frame: 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
Time frame: more than 24 weeks
hsCRP change
If information is collected, hsCRP change over 24 weeks compared to baseline
Time frame: more than 24 weeks
Plan to share: Undecided — Undecided
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Daewoong Pharmaceutical Co. LTD.