Clinical trial NCT05184179: Observational Study to Evaluate the Therapeutic Effectiveness and Safety of Olomax Tab
Official title: A Multi-center, Prospective, Observational Study to Evaluate the Therapeutic Effectiveness and Safety of Olomax Tab. for Patients With Hypertension and Dyslipidemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Dyslipidemia
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 5450
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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/exclusion criteria participates
4. The patient withdraws consent for the study
5. The administration of the study drug is discontinued
6. It is impossible to follow up during the observation period
7. The investigator determines that it is no longer feasible to continue the study

Primary outcomes:
measure: Blood pressure treatment goal achievement rate
timeFrame: more than 24 weeks
measure: LDL-C treatment goal achievement rate
timeFrame: more than 24 weeks
Secondary outcomes:
measure: Change in blood pressure
timeFrame: 24 to 48 weeks
measure: The proportion of patients who have reached the treatment goal at baseline and maintain the change in blood pressure and treatment goal
timeFrame: 24 to 48 weeks
measure: the percentage of patients maintaining the treatment goal and the amount of change in blood pressure
timeFrame: 24 to 48 weeks
measure: Patients who did not reach the treatment goal at baseline, change in blood pressure and rate of reaching the treatment goal
timeFrame: 24 to 48 weeks
measure: 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
timeFrame: 24 to 48 weeks
measure: Change in LDL-C
timeFrame: 24 to 48 weeks
measure: Among patients who reached the treatment goal at baseline, the change in LDL-C, the proportion of patients maintaining the treatment goal
timeFrame: 24 to 48 weeks
measure: Among patients who reached the treatment goal at baseline, the change in LDL-C , the proportion of eligible patients maintaining the treatment goal
timeFrame: 24 to 48 weeks
measure: For patients who did not reach the treatment goal at baseline, change in LDL-C, rate of reaching the treatment goal
timeFrame: 24 to 48 weeks
measure: For patients who did not reach the treatment goal at baseline, change in LDL-C, rate of reaching the treatment goal
timeFrame: 24 to 48 weeks
measure: Change amount and rate of change in lipid variables
timeFrame: 24 to 48 weeks
measure: the rate and amount of change in both blood pressure and LDL-C
timeFrame: more than 24 weeks
measure: Change in Framingham Risk Score (FRS)
timeFrame: more than 24 weeks
measure: change in carotid intima-media thickening (CIMT) value
timeFrame: more than 24 weeks
measure: hsCRP change
timeFrame: more than 24 weeks
Other outcomes:
Locations:
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
state: Gyeonggi
Study officials:
References: