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Clinical trial

A Randomization, Double-blind, Active-controlled, Multicenter, Phase 3 Trial to Evaluate the Efficacy and Safety of AD-224A and AD-224B in Patients With Essential Hypertension

ID
Name
AD-224P3
Description
The purpose of this study is to evaluate the efficacy and safety of AD-224
Trial arms
Trial start
2024-04-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
AD-224A
PO, Once daily, 8weeks
Arms:
AD-224A
AD-224B
PO, Once daily, 8weeks
Arms:
AD-224B
AD-224C
PO, Once daily, 8weeks
Arms:
AD-224C
Placebo of AD-224A
PO, Once daily, 8weeks
Arms:
AD-224B, AD-224C
Placebo of AD-224B
PO, Once daily, 8weeks
Arms:
AD-224A, AD-224C
Placebo of AD-224C
PO, Once daily, 8weeks
Arms:
AD-224A, AD-224B
Size
252
Primary endpoint
Change rate of MSSBP
Baseline, Week 8
Eligibility criteria
Inclusion Criteria: * Signed informed consent * Patients with Essential Hypertension * Other inclusions applied Exclusion Criteria: * Patient with Secondary Hypertension * Other exclusions applied
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 252, 'type': 'ESTIMATED'}}
Updated at
2024-03-06

1 organization

3 products

1 indication

Product
AD-224A
Indication
Hypertension,Essential
Product
AD-224B
Product
AD-224C
Organization
Addpharma