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NCT04686643 Clinical Trial

Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension

Hypertension Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04686643
Other study ID # AGSAVI1705
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date February 1, 2021
Est. completion date May 1, 2022

Study information
Verified date December 2020
Source Ahn-Gook Pharmaceuticals Co.,Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A phase 3 study to evaluate efficacy and safety of AGSAVI

Description:

A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of AGSAVI for Inadequately Controlled with AGLS

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 306
Est. completion date May 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Hypertension patient who satisfied below condition at Visit 1. - patient who takes antihypertensive drug - 140mmHg <= sitSBP <= 200mmHg - patient who doesn't take antihypertensive drug - 160mmHg <= sitSBP <= 200mmHg - Hypertension patient who satisfied below condition at Visit 2. - 140mmHg <= sitSBP <= 200mmHg at Visit 2 - 130mmHg <= sitSBP <= 200mmHg at Visit 2(In high-risk patients) Exclusion Criteria: - Patient who have received 4 or more antihypertensive drug - Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 2 times of BP measuring at Visit 1 - Patient with sitDBP >= 120mmHg at Visit 1 or 2 - Patient with secondary hypertension

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AGSAVI
S-amlodipine, Valsartan, Indapamide
• AGLS
S-amlodipine, Valsartan

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in sitSBP at week 10 10 weeks
Secondary Change from baseline in sitting diastolic blood pressure at week 4 and week 10 week 4 and week 10
Secondary Change from baseline in sitting systolic blood pressure at week 4 week 4
Secondary •Proportion of subjects achieving Blood Pressure control week 4 and week 10
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