NCT04554303

Comparing Safety and Efficacy of Amlodipine Verses S Amlodipine in Patients With Essential Hypertension

A 12 Weeks, Multi-center, Randomized, Open Label, Active Control, Phase IV Clinical Trial to Compare Evaluated Improvement of Edema Index, Safety and Efficacy of Amlodipine Versus S Amlodipine in Patients With Essential Hypertension

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	S-amlodipine 2.5mg	Oral administration, 1 tablet per day
DRUG	Amlodipine 5mg	Oral administration, 1 tablet per day

Timeline

• Start date: 2020-10-28
• Primary completion: 2022-05-23
• Completion: 2022-05-23
• First posted: 2020-09-18
• Last updated: 2020-11-12

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study