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NCT05503953 Clinical Trial

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

Essential 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 NCT05503953
Other study ID # AG-1705_P3
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date September 5, 2022
Est. completion date July 31, 2024

Study information
Verified date August 2022
Source Ahn-Gook Pharmaceuticals Co.,Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 306
Est. completion date July 31, 2024
Est. primary completion date February 29, 2024
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 <= MSSBP < 200mmHg - 130mmHg <= MSSBP < 200mmHg at or before visit 1(In high-risk patients) - patient who doesn't take antihypertensive drug - 160mmHg <= MSSBP < 200mmHg - Hypertension patient who satisfied below condition at Visit 2. - 140mmHg <= MSSBP < 200mmHg at Visit 2 - 130mmHg <= MSSBP < 200mmHg at or before Visit 1(In high-risk patients) Exclusion Criteria: - Patient who have received 4 or more antihypertensive drug - Patient with 20mmHg>= of difference in MSSBP or 10mmHg>= of difference in MSDBP between 2 times of BP measuring at Visit 1 - Patient with MSDBP >= 120mmHg at Visit 1 or 2 - Patient with secondary hypertension(including past medical history)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AGSAVI
Uptitation
• AGLS
Uptitration

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd Daehwa Pharmaceutical Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Change of MSSBP(Mean Sitting Systolic Blood Pressure) Change of MSSBP(Mean Sitting Systolic Blood Pressure) From Baseline to Visit 5(For 10 weeks) From Baseline(Visit 2) to Visit 5(For 10 weeks)
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