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

Sponsor

Handok Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05476354

Collaborator

(none)

273

Enrollment

Location

Arms

Anticipated Duration (Months)

45.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: Irbesartan/Amlodipine low Drug: Irbesartan/Amlodipine high Drug: Irbesartan	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

273 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase 3 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Irbesartan/Amlodipine low	Drug: Irbesartan/Amlodipine low Irbesartan/Amlodipine low once daily for 8 weeks
Experimental: Irbesartan/Amlodipine high	Drug: Irbesartan/Amlodipine high Irbesartan/Amlodipine high once daily for 8 weeks
Active Comparator: Irbesartan	Drug: Irbesartan Irbesartan once daily for 8 weeks

Arm

Intervention/Treatment

Experimental: Irbesartan/Amlodipine low

Drug: Irbesartan/Amlodipine low

Irbesartan/Amlodipine low once daily for 8 weeks

Experimental: Irbesartan/Amlodipine high

Drug: Irbesartan/Amlodipine high

Irbesartan/Amlodipine high once daily for 8 weeks

Active Comparator: Irbesartan

Drug: Irbesartan

Irbesartan once daily for 8 weeks

Outcome Measures

Primary Outcome Measures

Change from baseline in mean sitting systolic blood pressure(mmHg) [Week8]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

Handok Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Handok Inc.

ClinicalTrials.gov Identifier:

NCT05476354

Other Study ID Numbers:

HD-AI-301

First Posted:

Jul 27, 2022

Last Update Posted:

Jul 27, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Essential Hypertension

Amlodipine

Irbesartan

Study Results

No Results Posted as of Jul 27, 2022