Observational Study to Evaluate the Therapeutic Effectiveness and Safety of Olomax Tab
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Blood pressure treatment target achievement rate [After more than 24 weeks of Olomax Tab. administration to 48 weeks(+8 weeks)]
Evaluation of blood pressure treatment target achievement rate against baseline
- LDL-C treatment target achievement rate [After more than 24 weeks of Olomax Tab. administration to 48 weeks(+8 weeks)]
Evaluation of LDL-C treatment target achievement rate against baseline
Secondary Outcome Measures
- Amount of blood pressure change [at 24 weeks, at 48 weeks]
The amount of blood pressure change from 24 weeks to 48 weeks compared to the baseline.
- Rate of change in blood pressure [at 24 weeks, at 48 weeks]
The rate of change in blood pressure and the proportion of patients who maintain the treatment goal at the point of 48 weeks or more as patients who have reached the baseline.
- The rate of patients who maintain their Blood Pressure treatment goals [at 24 weeks, at 48 weeks]
The rate of patients who maintain their treatment goals at 48 weeks (who have reached their treatment goals on the baseline and the rate of change in blood pressure by anti-hypertensive drug (single, two-component complex classification))
- Blood pressure changes and treatment target attainment rate [at 24 weeks, at 48 weeks]
Blood pressure changes and treatment target attainment rate at the time of more than 24 weeks and 48 weeks as patients who have not reached the baseline.
- Amount of change in blood pressure and the rate of reaching the treatment target [at 24 weeks, at 48 weeks]
The amount of change in blood pressure and the rate of reaching the treatment target at the time of 48 weeks or more of the patients who have not reached the treatment target on the baseline (single, complex classification) for each anti-hypertensive drug
- The amount of LDL-C change [at 24 weeks, at 48 weeks]
The amount of LDL-C change from 24 weeks to 48 weeks compared to the baseline.
- The amount of LDL-C change and percentage of patients who have reached the baseline [at 24 weeks, at 48 weeks]
The amount of LDL-C change and percentage of patients who have reached the baseline and maintain the treatment goal at the point of 48 weeks or more.
- The rate of LDL-C change and rate of patients maintaining the treatment target [at 24 weeks, at 48 weeks]
The rate of LDL-C change and rate of patients maintaining the treatment target at the time of 24 to 48 weeks by anti-lipidemia agent as patients who have reached the baseline.
- The amount of LDL-C change and treatment target attainment rate [at 24 weeks, at 48 weeks]
The amount of LDL-C change and treatment target attainment rate at the time of more than 24 weeks and 48 weeks as patients who have not reached the baseline.
- the amount of LDL-C change and the rate of reaching the treatment target of patients who have not reached the treatment target on baseline [at 24 weeks, at 48 weeks]
Patients who have not reached the treatment target on the baseline, the amount of LDL-C change and the rate of reaching the treatment target at the time of 48 weeks or more by anti-abnormal lipidemia drug
- The amount and rate of change of lipid variables [at 24 weeks, at 48 weeks]
The amount and rate of change of lipid variables (Non-HDL, HDL-C, TG, TC) at 24 to 48 weeks relative to the baseline.
- Framingham Risk Score (FRS) change [at 24 weeks, at 48 weeks]
Framingham Risk Score (FRS) changes compared to baseline. less than 10% : low risk 10% to 20%: intermediate risk over 20%: high risk
- Variation of Carotid Intima-Media Thickness Carotid Intima-Media Thickness (CIMT) levels in the presence of data [at 24 weeks, at 48 weeks]
Variation of Carotid Intima-Media Thickness Carotid Intima-Media Thickness (CIMT) levels in the presence of data
- hsCRP change [at 24 weeks, at 48 weeks]
hsCRP change compared to hsCRP measured at baseline visit
- Average value of medication compliance [at 24 weeks, at 48 weeks]
Medication compliance at 24 weeks, at 48 weeks. The smaller the average value of medication compliance, the better the medication compliance
Eligibility Criteria
Criteria
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.
-
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.
- Consent on the use of information by the patient
Exclusion Criteria:
-
Patients who have already administered olomax tablets.
-
Subject who fall under ' Do not administer to the following patients' in the precautions for use
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hallym University Dongtan Sacred Heart Hospital | Hwaseong-si | Gyeonggi | Korea, Republic of | 18450 |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DWJ1351_P402