The purpose of this study is to evaluate the efficacy and safety of OLOMAX Tab (20/5/5mg, 20/5/10mg) in Hypertension Patients with Low-Intermediate Risk for Cardiovascular Disease.
The patients who meet the inclusion/exclusion criteria will be randomized 1:1:1 to test group 1 (olomax tablet 20/5/5mg), test group 2 (olomax tablet 20/5/10mg), and control group (sevica tablet 5/20mg. After randomization, the drug will be administered for 8 weeks according to the assigned group. During the administration period, subjects will conduct a total of three outpatient visits at 4 weeks (Visit 3) and 8 weeks (Visit 4, EOS), including randomized visits (Visit 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Daewoong pharmatceutical
Seoul, South Korea
mLDL-C change rate (%)
mLDL-C change rate (%) at 8 weeks after administration compared to baseline in test group 1 and control group
Time frame: 8 weeks
mLDL-C change rate
mLDL-C change rate (%) at 8 weeks after administration compared to baseline in test group 2 and control group
Time frame: 8 weeks
Change rate (%) in mLDL-C
Change rate (%) in mLDL-C at 4 weeks of administration of investigational drug compared to baseline
Time frame: 4 weeks
cLDL-C* change rate
cLDL-C\* change rate (%) at 4 weeks of administration of investigational drug compared to baseline
Time frame: 4 weeks
cLDL-C* change rate
cLDL-C\* change rate (%) at 8 weeks of administration of investigational drug compared to baseline
Time frame: 8 weeks
Change amount and rate of change (%) in each of the following lipid indicators
Change amount and rate of change (%) in each of the following lipid indicators at 4 weeks of administration of the investigational drug compared to the baseline
Time frame: 4 weeks
Change amount and rate of change (%) in each of the following lipid indicators
Change amount and rate of change (%) in each of the following lipid indicators at 8 weeks of administration of the investigational drug compared to the baseline
Time frame: 8 weeks
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Proportion of test subjects with mLDL-C less than 70 mg/dL
Proportion of test subjects with mLDL-C less than 70 mg/dL at 4 weeks of administration of investigational drug (%)
Time frame: 4 weeks
Proportion of test subjects with mLDL-C less than 70 mg/dL
Proportion of test subjects with mLDL-C less than 70 mg/dL at 8 weeks of administration of investigational drug (%)
Time frame: 8 weeks
Proportion of test subjects with mLDL-C less than 100 mg/dL
Proportion of test subjects with mLDL-C less than 100 mg/dL at 4 weeks of administration of investigational drug (%)
Time frame: 4 weeks
Proportion of test subjects with mLDL-C less than 100 mg/dL
Proportion of test subjects with mLDL-C less than 100 mg/dL at 8 weeks of administration of investigational drug (%)
Time frame: 8 weeks
Change and rate of change in sitSBP (%)
Change and rate of change in sitSBP (%) at 4 weeks of administration of investigational drug compared to baseline
Time frame: 4 weeks
Change and rate of change in sitDBP (%)
Change and rate of change in sitDBP (%) at 8 weeks of administration of investigational drug compared to baseline
Time frame: 8 weeks
Blood pressure normalization* rate (%
Blood pressure normalization\* rate (%) at 8 weeks after administration of investigational drug
Time frame: 8 weeks
Change amount and rate of change (%)
Change amount and rate of change (%) in each of the following sugar indicators at 4 weeks of administration of the investigational drug compared to the baseline
Time frame: 4 weeks
Change amount and rate of change (%)
Change amount and rate of change (%) in each of the following sugar indicators at 8 weeks of administration of the investigational drug compared to the baseline
Time frame: 8 weeks