As a third-generation dihydropyridine calcium channel blocker (CCB), Amlodipine is mainly used in a single therapy or combined therapy for hypertension or angina. Edema, one of the most common side effects of dihydropyridine CCB formulations, may lead to drug control or discontinuation of drugs. This clinical study intends to assess the safety and efficacy of S-amlodipine, which is assessed to be superior to Amlodipine in the aspects of antihypertensive effect and side effects, in edema of patients with essential hypertension.
1. Clinical Study Design \- In this clinical study, Part 1 is conducted as a preliminary study on 10 subjects at a single center, and based on the results of Part 1, the sponsor and the principal investigator determine whether to proceed with Part 2. With Part 2 as the multicenter main study conducted on the remaining 70 subjects, 80 subjects in total have been planned for Part 1 and Part 2. 2. Interim analysis \- The interim analysis is conducted when the study on 10 subjects at a Part 1 single center has been completed; the analysis is made on all endpoints planned for this clinical study. 3. Clinical study methods - During screening, subjects who have voluntarily signed the Informed Consent Form are tested for eligibility to this clinical study. After a wash-out period of at least two weeks, subjects who satisfy the inclusion/exclusion criteria are randomly assigned to two groups (S-amlodipine group, Amlodipine group). Thereafter, the subjects are enrolled and orally administered with the investigational product once a day for 12 weeks, during which they receive a total of five visits for tests conducted for assessment of efficacy and safety. (In case of confirmed eligibility without administration of contraindications, the wash-out period may be omitted and Visits 1 and 2 may be paid on the same day)
Study Type
OBSERVATIONAL
Enrollment
80
Oral administration, 1 tablet per day
Oral administration, 1 tablet per day
Korea University Guro Hospital
Seoul, South Korea
RECRUITINGThe variance in edema index [Extracellular water (ECW) / total body water (TBW)] using Inbody measurement between groups at week 12, compared to the baseline.
Descriptive statistics (number of observation subjects, mean, standard deviation, median, minimum, maximum) are summarized by treatment group. Depending on whether there is a difference in the variance between treatment groups (S-amlodipine group, Amlodipine group) that satisfies the normality assumption, analysis is made using either two sample t-test or Wilcoxon's rank sum test.
Time frame: Edema indexs (ECW/TBW) are measured at week 4, 8, 12 of treatment.
The variance in edema index between groups at weeks 4 and 8, compared to the baseline
Descriptive statistics (number of observation subjects, mean, standard deviation, median, minimum, maximum) are summarized by treatment group. Depending on whether there is a difference in the variance between treatment groups (S-amlodipine group, Amlodipine group) that satisfies the normality assumption, analysis is made using either two sample t-test or Wilcoxon's rank sum test.
Time frame: Edema indexs (ECW/TBW) are measured at week 4, 8, 12 of treatment.
The variance in ankle size (mean size of both ankles using a medical tape measure) between groups at weeks 4, 8, and 12, compared to the baseline.
Mean size of both anckles are tape-measured using medical tape.
Time frame: Ankel sizes are measured in at week 4, 8, and 12 of treatment.
The variance in edema index (extracellular moisture per site/water per site) by site (body, right arm, left arm, trunk, right leg, left leg) between groups at weeks 4, 8, and 12, compared to the baseline.
Descriptive statistics (number of observation subjects, mean, standard deviation, median, minimum, maximum) are summarized by site(body, right arm, left arm, trunk, right leg, left leg) and treatment group. Depending on whether there is a difference in the variance between treatment groups (S-amlodipine group, Amlodipine group) that satisfies the normality assumption, analysis is made using either two sample t-test or Wilcoxon's rank sum test.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Edema indexs (ECW/TBW) by site (body, right arm, left arm, trunk, right leg, left leg) are measured at the week 4, 8, and 12 of treatment.
The variance in blood pressure between groups at weeks 4, 8, and 12, compared to the baseline.
Blood pressure is measured at five-minute intervals after a five-minute rest while seated; three measurements are made for one arm and the SBP and DBP values at each measurement are collected and calculated to derive the mean value.
Time frame: Blood pressure are measured at week 4, 8, and 12 of treatment.