Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

Phase 3

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: Irbesartan/Amlodipine low; Drug: Irbesartan/Amlodipine high; Drug: Irbesartan

• Registration Number: NCT05476354
• Lead Sponsor: Handok Inc.

Brief Summary

The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-05
• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-07-24
• Study First Posted: 2022-07-27
• Primary Completion: 2023-04-03
• Study Completion: 2023-06-13
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

Inclusion Criteria

• Patients who are 19 years or older on screening
• Signed informed consent
• Patients with Essential Hypertension
• Other inclusion applied

Exclusion Criteria

• Orthostatic hypotension
• Other exclusion applied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irbesartan/Amlodipine low	Irbesartan/Amlodipine low	-
Irbesartan/Amlodipine high	Irbesartan/Amlodipine high	-
Irbesartan	Irbesartan	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting systolic blood pressure(mmHg)	Week8

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting systolic blood pressure(mmHg)	Week 4
Target blood pressure reach rate	Week 4,8
Responder rate	Week 4,8
2.Change from baseline in mean sitting diastolic blood pressure(mmHg)	Week 4,8

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of