Back to resultsPhase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Irbesartan/Amlodipine
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 / 75 years or younger on screening
- Signed informed consent
- Patients with Essential Hypertension
- Other inclusion applied
Exclusion Criteria:
- Orthostatic hypertension with symptom
- Other exclusion applied
Sites / Locations
- Yonsei University Health System, Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Irbesartan low/Amlodipine low
Irbesartan low/Amlodipine high
Irbesartan high/Amlodipine low
Irbesartan high/Amlodipine high
Amlodipine low
Amlodipine high
Irbesartan low
Irbesartan high
Arm Description
Irbesartan low & Amlodipine low, once daily for 8 weeks
Irbesartan low & Amlodipine high, once daily for 8 weeks
Irbesartan high & Amlodipine low, once daily for 8 weeks
Irbesartan high & Amlodipine high, once daily for 8 weeks
Amlodipine low, once daily for 8 weeks
Amlodipine high, once daily for 8 weeks
Irbesartan low, once daily for 8 weeks
Irbesartan high, once daily for 8 weeks
Outcomes
Primary Outcome Measures
The change in MSSBP between baseline and Week8.
The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.
Secondary Outcome Measures
The change in MSSBP between baseline and Week4.
The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.
The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04488978
Brief Title
Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension
Official Title
A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
November 9, 2021 (Actual)
Study Completion Date
November 9, 2021 (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
A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypertension
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 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Irbesartan low/Amlodipine low
Arm Type
Experimental
Arm Description
Irbesartan low & Amlodipine low, once daily for 8 weeks
Arm Title
Irbesartan low/Amlodipine high
Arm Type
Experimental
Arm Description
Irbesartan low & Amlodipine high, once daily for 8 weeks
Arm Title
Irbesartan high/Amlodipine low
Arm Type
Experimental
Arm Description
Irbesartan high & Amlodipine low, once daily for 8 weeks
Arm Title
Irbesartan high/Amlodipine high
Arm Type
Experimental
Arm Description
Irbesartan high & Amlodipine high, once daily for 8 weeks
Arm Title
Amlodipine low
Arm Type
Active Comparator
Arm Description
Amlodipine low, once daily for 8 weeks
Arm Title
Amlodipine high
Arm Type
Active Comparator
Arm Description
Amlodipine high, once daily for 8 weeks
Arm Title
Irbesartan low
Arm Type
Active Comparator
Arm Description
Irbesartan low, once daily for 8 weeks
Arm Title
Irbesartan high
Arm Type
Active Comparator
Arm Description
Irbesartan high, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Irbesartan/Amlodipine
Intervention Description
QID
Primary Outcome Measure Information:
Title
The change in MSSBP between baseline and Week8.
Description
The primary efficacy variable was the change in Mean Sitting Systolic Blood Pressure between baseline and Week8.
Time Frame
Baseline and Week8
Secondary Outcome Measure Information:
Title
The change in MSSBP between baseline and Week4.
Time Frame
Baseline and Week4
Title
The change in Mean Sitting Diastolic Blood Pressure between baseline and Week4 / Week8.
Time Frame
Baseline and Week4/8
Title
The proportion of patients having reached MSSBP < 140 mmHg and MSDBP < 90 mmHg at W4 and at W8.
Time Frame
Baseline and Week4/8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are 19 years or older / 75 years or younger on screening
Signed informed consent
Patients with Essential Hypertension
Other inclusion applied
Exclusion Criteria:
Orthostatic hypertension with symptom
Other exclusion applied
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension
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