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
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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)

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

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)