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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Irbesartan/Amlodipine low
Irbesartan/Amlodipine high
Irbesartan
Sponsored by
Handok Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Irbesartan/Amlodipine low

Irbesartan/Amlodipine high

Irbesartan

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in mean sitting systolic blood pressure(mmHg)
2.Change from baseline in mean sitting diastolic blood pressure(mmHg)
Responder rate
Target blood pressure reach rate

Full Information

First Posted
July 24, 2022
Last Updated
August 15, 2023
Sponsor
Handok Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05476354
Brief Title
Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
April 3, 2023 (Actual)
Study Completion Date
June 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Handok Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Irbesartan/Amlodipine low
Arm Type
Experimental
Arm Title
Irbesartan/Amlodipine high
Arm Type
Experimental
Arm Title
Irbesartan
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Irbesartan/Amlodipine low
Intervention Description
Irbesartan/Amlodipine low once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Irbesartan/Amlodipine high
Intervention Description
Irbesartan/Amlodipine high once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Intervention Description
Irbesartan once daily for 8 weeks
Primary Outcome Measure Information:
Title
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame
Week8
Secondary Outcome Measure Information:
Title
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame
Week 4
Title
2.Change from baseline in mean sitting diastolic blood pressure(mmHg)
Time Frame
Week 4,8
Title
Responder rate
Time Frame
Week 4,8
Title
Target blood pressure reach rate
Time Frame
Week 4,8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

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

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