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

N/AActive Not RecruitingNCT05411887

Daewoong Pharmaceutical Co. LTD.2,845 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,845

Conditions

Hyperlipidemias Hypertension

Interventions

Rosuvastatin, Olmesartan MedoxomilDRUG

Olostar Tablet

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C)

Evaluation of absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C) compared to baseline

Time frame: 24 weeks

absolute change and rate of change in systolic and diastolic blood pressure

Evaluation of absolute change and rate of change in systolic and diastolic blood pressure compared to baseline

Time frame: 24 weeks

Secondary Outcomes

Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals

Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals assessed 6 months after administration of Olosta tablets

Time frame: 24 weeks

LDL-C treatment goal achievement rate

LDL-C treatment goal achievement rate at 24 weeks

Time frame: 24 weeks

Blood pressure treatment goal achievement rate

Blood pressure treatment goal achievement rate at 24 weeks

Time frame: 24 weeks

Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg

Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg at 24 weeks

Time frame: 24 weeks

Olostar tablet compliance

Olostar tablet compliance at 24 weeks

Data from ClinicalTrials.gov

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