Clinical trial NCT05660135: Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia
Official title: Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia: a Multi-center-database Real-world Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertension
Dyslipidemias
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-12-21
Enrollment: 4000
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: This study is to confirm the effect of olomax tablet -reducing blood pressure and LDL-C- in patients with hypertension and dyslipidemia compared to existing drugs . Of the total 4,672,648 statin prescriptions in 2020, about 295,379 were combined prescriptions for hypertension treatment. It was expected that about 1% of them could be registered, and therefore we estimated 4,000 study subjects to be recruited.

Brief summary: This study is a large-scale, prospective, multi-center, and non-interventional observation study to observe blood pressure and blood lipid changes and safety during administration of olomax tablets for 24 weeks in hypertensive patients with dyslipidemia.

Detailed description: In this study, investigator will evaluate subjects' clinical performance in actual care. Laboratory test results such as demographic information and medical treatment, blood pressure, blood lipid test, and liver function test conducted at the start date of Olomax tablet administration and subsequent 24 weeks (± 8 weeks) will be collected. In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.

Eligibility criteria: Inclusion Criteria:

1. Adult aged 19 or older at the time of the baseline visit.
2. A patient with hypertension and dyslipidemia who is scheduled to administer olomax tablet according to investigator's medical judgement.

   * Patients who were previously taking more than two tablets of a single drug, low-density lipoprotein-cholesterol (LDL-C)
   * Patients who were previously only taking blood pressure-lowering drugs and did not take LDL-C-lowering drugs, but who need to take additional LDL-C-lowering drugs at the discretion of the researcher
   * Patients who were previously taking LDL-C lowering agents and did not take blood pressure lowering agents, but who need to take additional blood pressure lowering agents according to the researcher's judgment
   * Patients who have not previously taken both a blood pressure drop and an LDL-C drop but need additional simultaneous use at the discretion of the researcher
3. A person who can understand the information provided to him/her and may voluntarily sign a written consent form

Exclusion Criteria:

1. A person who falls under the prohibition of administration according to the permission for olomax tablet
2. A person who has a history of administering olomax tablets before participating in this study
3. In addition to the above, a person that the investigator thinks he/she is not suitable for participating in this observation study;

Primary outcomes:
measure: The rate of change in LDL-C
timeFrame: at 24 weeks
measure: The amount of change in LDL-C
timeFrame: at 24 weeks
Secondary outcomes:
measure: The rate of change in LDL-C
timeFrame: at 12 weeks
measure: The amount of change in LDL-C
timeFrame: at 12 weeks
measure: The rate of change in SBP(Systolic Blood Pressure)
timeFrame: 12 weeks
measure: The rate of change in SBP(Systolic Blood Pressure)
timeFrame: 24 weeks
measure: The amount of change in SBP(Systolic Blood Pressure)
timeFrame: 12 weeks
measure: The amount of change in SBP(Systolic Blood Pressure)
timeFrame: 24 weeks
measure: The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
timeFrame: 12 weeks
measure: The rate of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
timeFrame: 24 weeks
measure: The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
timeFrame: 12 weeks
measure: The amount of change in lipid variable(TC, HDL-C, non-HDL-C, TG)
timeFrame: 24 weeks
measure: Percentage of subjects who reached LDL-C target
timeFrame: 12 weeks
measure: Percentage of subjects who reached LDL-C target
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Hun-Sung Kim
role: PRINCIPAL_INVESTIGATOR
References: