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Clinical trial

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

ID
Name
HD-AI-301
Description
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 arms
Trial start
2022-07-05
Estimated PCD
2023-04-03
Trial end
2023-06-13
Status
Completed
Phase
Early phase I
Treatment
Irbesartan/Amlodipine low
Irbesartan/Amlodipine low once daily for 8 weeks
Arms:
Irbesartan/Amlodipine low
Irbesartan/Amlodipine high
Irbesartan/Amlodipine high once daily for 8 weeks
Arms:
Irbesartan/Amlodipine high
Irbesartan
Irbesartan once daily for 8 weeks
Arms:
Irbesartan
Size
271
Primary endpoint
Change from baseline in mean sitting systolic blood pressure(mmHg)
Week8
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 271, 'type': 'ACTUAL'}}
Updated at
2023-08-18

1 organization

3 products

1 indication

Organization
Handok
Product
Irbesartan + Amlodipine
Indication
Hypertension
Product
Irbesartan/Amlodipine
Product
Irbesartan