Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients
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
1 other identifier
interventional
271
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2022
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2022
CompletedFirst Submitted
Initial submission to the registry
July 24, 2022
CompletedFirst Posted
Study publicly available on registry
July 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2023
CompletedAugust 18, 2023
August 1, 2023
9 months
July 24, 2022
August 15, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in mean sitting systolic blood pressure(mmHg)
Week8
Secondary Outcomes (4)
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
Study Arms (3)
Irbesartan/Amlodipine low
EXPERIMENTALIrbesartan/Amlodipine high
EXPERIMENTALIrbesartan
ACTIVE COMPARATORInterventions
Irbesartan/Amlodipine low once daily for 8 weeks
Irbesartan/Amlodipine high once daily for 8 weeks
Eligibility Criteria
You may qualify if:
- Patients who are 19 years or older on screening
- Signed informed consent
- Patients with Essential Hypertension
You may not qualify if:
- Orthostatic hypotension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Handok Inc.lead
Study Sites (1)
Severance Hospital
Seoul, 03722, South Korea
Related Publications (1)
Lee HY, Min KW, Han KA, Kim JS, Ahn JC, Kim MH, Lee JB, Shin SH, Kim CJ, Kim KH, Cho DK, Choi J, Rhee MY, Her SH, Kim W, Na JO, Cho GY, Kim SY, Park GM, Lee BK, Jo SH, Lee BW, Sohn IS, Kim DI, Ihm SH, Lee SH, Chung JW, Cho EJ, Son JW, Oh SJ, Hwang JY, Jeong JO, Han KR, Yoon HJ, Seo SM, Chung WJ, Bae JW, Choi JH, Hyun BJ, Cha JE, Yoo SJ, Shin J. The Efficacy and Tolerability of Irbesartan/Amlodipine Combination Therapy in Patients With Essential Hypertension Whose Blood Pressure Were not Controlled by Irbesartan Monotherapy. Clin Ther. 2024 Jun;46(6):481-489. doi: 10.1016/j.clinthera.2024.04.004. Epub 2024 May 3.
PMID: 38704294DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2022
First Posted
July 27, 2022
Study Start
July 5, 2022
Primary Completion
April 3, 2023
Study Completion
June 13, 2023
Last Updated
August 18, 2023
Record last verified: 2023-08