Back to resultsClinical Efficacy and Safety Evaluation of Irbesartan High 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
Irbesartan
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
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 with symptom
- Other exclusion applied
Sites / Locations
- Hanyang University Seoul Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Irbesartan/Amlodipine
Irbesartan
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in mean sitting systolic blood pressure (mmHg)
Secondary Outcome Measures
Change form baseline in mean sitting systolic blood pressure (mmHg)
Change form baseline in mean sitting diastolic blood pressure (mmHg)
Responder rate
Target blood pressure reach rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05475665
Brief Title
Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients
Official Title
A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase # 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 14, 2022 (Actual)
Primary Completion Date
March 30, 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
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
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Irbesartan/Amlodipine
Arm Type
Experimental
Arm Title
Irbesartan
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Irbesartan/Amlodipine
Intervention Description
Irbesartan/Amlodipine 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
Week 8
Secondary Outcome Measure Information:
Title
Change form baseline in mean sitting systolic blood pressure (mmHg)
Time Frame
Week 4
Title
Change form 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 with symptom
Other exclusion applied
Facility Information:
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Efficacy and Safety Evaluation of Irbesartan High and Amlodipine Combined Therapy in Essential Hypertension Patients
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