Clinical trial NCT05411887: Study to Evaluate the Effect of Improving Systolic BP and LDL-C Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab
Official title: A Non-interventional, Multi Center, Prospective Observational Study to Evaluate the Effect of Improving Systolic Blood Pressure and Low-density Lipoprotein Cholesterol Compared to Conventional Treatments and the Convenience of Taking Medication of Olostar Tab. in Patients With Essential Hypertension and Dyslipidemia.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hyperlipidemias
Hypertension
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 2845
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3000 subjects is a sufficient number to produce a meaningful model considering discriminant analysis and regression analysis that will be conducted in the secondary evaluation

Brief summary: The purpose of this study is to evaluate the effectiveness of Olostar Tablet on blood pressure and lipid profiles, obtain safety-related information for subgroups that failed to participate in the clinical trials, and to evaluate variables that affect treatment effectiveness.


Eligibility criteria: Inclusion Criteria:

1. men and women over the age of 19
2. Patients who signed a written consent form to participate in the study
3. Patients who are eligible for Olostar tablet prescription according to domestic permission

Exclusion Criteria:

1. A person who falls under "2. Do not administer to the following patients" among the precautions for use in the user manual
2. Patients in hospital (hospitals only; nursing care facilities can be recruited)
3. A person who has been administered the study target drug or is being administered at the time of recruitment within 6 months based on the date of the study contract

Primary outcomes:
measure: absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C)
timeFrame: 24 weeks
measure: absolute change and rate of change in systolic and diastolic blood pressure
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals
timeFrame: 24 weeks
measure: LDL-C treatment goal achievement rate
timeFrame: 24 weeks
measure: Blood pressure treatment goal achievement rate
timeFrame: 24 weeks
measure: Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg
timeFrame: 24 weeks
measure: Olostar tablet compliance
timeFrame: 24 weeks
measure: Olostar tablet dose change
timeFrame: 24 weeks
measure: Olostar Tablet persistence
timeFrame: 24 weeks
measure: Evaluation of compliance
timeFrame: 24 weeks
measure: Assessment of Variables Influencing the Simultaneous Achievement of General
timeFrame: 24 weeks
measure: Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.)
timeFrame: 24 weeks
measure: Evaluation of variables affecting compliance and persistence with Olostar tablets
timeFrame: 24 weeks
measure: Evaluation of convenience of taking Olostar tablets
timeFrame: 24 weeks
measure: Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: JaeWon Oh
role: PRINCIPAL_INVESTIGATOR
References: