Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-28 @ 12:23 AM
Study NCT ID:
NCT04554303
Status:
UNKNOWN
Last Update Posted:
2020-11-12
First Post:
2020-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Safety and Efficacy of Amlodipine Verses S Amlodipine in Patients With Essential Hypertension
Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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)
\- 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: