Hyperlipidemias, Hypertension
Conditions
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.
Interventions
DRUGRosuvastatin, Olmesartan Medoxomil
Olostar Tablet
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C) | 24 weeks | Evaluation of absolute change and rate of change in low-density lipoprotein cholesterol (LDL-C) compared to baseline |
| absolute change and rate of change in systolic and diastolic blood pressure | 24 weeks | Evaluation of absolute change and rate of change in systolic and diastolic blood pressure compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure treatment goal achievement rate | 24 weeks | Blood pressure treatment goal achievement rate at 24 weeks |
| Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg | 24 weeks | Proportion of subjects who decreased systolic blood pressure by 20 mmHg and diastolic blood pressure by 10 mmHg at 24 weeks |
| Olostar tablet compliance | 24 weeks | Olostar tablet compliance at 24 weeks |
| Olostar tablet dose change | 24 weeks | Olostar tablet dose change: ① Proportion of subjects by initial dose, ② Average number of dose changes, ③ Proportion of subjects by dose at the end at 24 weeks |
| Olostar Tablet persistence | 24 weeks | Olostar Tablet persistence: ① persistence rate; ② Median time to discontinuation; ③ Evaluation of reasons for suspension |
| Proportion of subjects who achieved both general hypertension treatment goals and blood low-density lipoprotein cholesterol (LDL-C) treatment goals | 24 weeks | 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 |
| Assessment of Variables Influencing the Simultaneous Achievement of General | 24 weeks | Assessment of Variables Influencing the Simultaneous Achievement of General Treatment Goals for Hypertension and Low-Density Lipoprotein Cholesterol (LDL-C) Treatment Goals and the Creation of a Predictive Model at 24 weeks |
| Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.) | 24 weeks | Evaluation of variables affecting the frequency and severity of safety (adverse drug reactions, etc.) at 24 weeks |
| Evaluation of variables affecting compliance and persistence with Olostar tablets | 24 weeks | Evaluation of variables affecting compliance and persistence with Olostar tablets at 24 weeks |
| Evaluation of convenience of taking Olostar tablets | 24 weeks | Evaluation of convenience of taking Olostar tablets at 24 weeks |
| Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets | 24 weeks | Actual incidence of adverse events, adverse drug reactions, and serious adverse events in subjects receiving Olostar tablets at 24 weeks |
| Evaluation of compliance | 24 weeks | Evaluation of compliance with therapeutic lifestyle improvement (eating habits and amount of exercise) |
| LDL-C treatment goal achievement rate | 24 weeks | LDL-C treatment goal achievement rate at 24 weeks |
Countries
South Korea
Outcome results
None listed