This study purpose is to determine the appropriate combination drug dose by comparing safety and efficacy with placebo, candesartan, and amlodipine monotherapy after 8 weeks of administration of SPC1001 to patients with essential hypertension.
This clinical trial is a randomized, double-blind, parallel design, placebo and active drug comparison, and multicenter clinical trial to evaluate the safety and efficacy of investigational drugs after 8 weeks of administration. Subjects who meet the selection and exclusion criteria should take a placebo for 2 weeks during the run-in period and run a lifestyle improvement program in parallel. However, if you are already taking antihypertensive drugs at the time of screening, you should stop taking your existing antihypertensive drugs for at least 4 weeks from before the run-in period to the time of randomization to avoid affecting the clinical trial results. Subjects who meet the final selection and exclusion criteria at the end of the run-in period are randomly assigned 1:1:1:1:1:1:1:1 to each administration group, receive a prescription for clinical trial drugs, and administer for 8 weeks in a double-blind manner. Encourage the subjects to continuously perform the lifestyle improvement program for 8 weeks during the administration of the clinical investigational drug and visit the testing institution at 4 and 8 weeks during the 8-week trial period, excluding randomized visits, to check the efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
253
Drugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
Drugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
Drugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
CHA Gangnam Medical Center, CHA University
Seoul, Gangnam, South Korea
MSSBP measures the amount of change after 8 weeks from baseline
MSSBP measures the amount of change after 8 weeks from baseline
Time frame: 8 weeks from baseline
MSSBP measures the amount of change after 4 weeks from baseline
MSSBP measures the amount of change after 4 weeks from baseline
Time frame: 4 weeks from baseline
MSDBP measures the amount of change after 4 weeks, 8 weeks from baseline
MSDBP measures the amount of change after 4 weeks, 8 weeks from baseline
Time frame: 4, 8 weeks from baseline
blood pressure normalization rate
The Proportion of subjects who reached target blood pressure at 4 and 8 weeks of administration of the clinical trial drug
Time frame: 4, 8 weeks from baseline
blood pressure response rate
The proportion of subjects whose MSSBP decreased by 20 mmHg or more and/or MSDBP decreased by 10 mmHg or more compared to baseline at 4 or 8 weeks after administration of the clinical trial drug
Time frame: 4, 8 weeks from baseline
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Drugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
Drugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
Drugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
Drugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
Drugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.