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Clinical trial

A Multicenter, Randomized, Double-blind, Active-control, Phase III Study to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension

ID
Name
AD-209P3
Description
The purpose of this study is to evaluate the efficacy and safety of AD-209
Trial arms
Trial start
2024-04-01
Estimated PCD
2025-02-01
Trial end
2025-02-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
AD-209
PO, Once daily(QD), 8weeks
Arms:
Test group
AD-2091
PO, Once daily(QD), 8weeks
Arms:
Control group
AD-209 Placebo
PO, Once daily(QD), 8weeks
Arms:
Control group
AD-2091 Placebo
PO, Once daily(QD), 8weeks
Arms:
Test group
Size
280
Primary endpoint
Change rate of MSSBP
Baseline, Week 8
Eligibility criteria
Inclusion Criteria: * Signed informed consent * Other inclusions applied Exclusion Criteria: * Orthostatic hypotension with symptom * Other exclusions applied
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}
Updated at
2024-04-04

1 organization

2 products

1 indication

Organization
Addpharma
Product
AD-209
Indication
Hypertension,Essential
Product
AD-2091