Clinical trial
A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension
Name
AD-209P2-02
Description
The purpose of this study is to evaluate the efficacy and safety of AD-209
Trial arms
Trial start
2023-04-05
Estimated PCD
2023-11-27
Trial end
2023-11-27
Status
Completed
Phase
Early phase I
Treatment
AD-209
PO, Once daily(QD), 8weeks
Arms:
Experimental 1
AD-209-1A
PO, Once daily(QD), 8weeks
Arms:
Experimental 2
AD-209-1B
PO, Once daily(QD), 8weeks
Arms:
Experimental 3
AD-209-1C
PO, Once daily(QD), 8weeks
Arms:
Experimental 4
AD-209 placebo
PO, Once daily(QD), 8weeks
Arms:
Experimental 2, Experimental 3, Experimental 4
AD-209-1 placebo
PO, Once daily(QD), 8weeks
Arms:
Experimental 1
Size
221
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': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 221, 'type': 'ACTUAL'}}
Updated at
2024-04-05
1 organization
5 products
2 indications
Organization
AddpharmaProduct
AD-209Indication
HypertensionIndication
EssentialProduct
AD-209-1Product
AD-209-1AProduct
AD-209-1BProduct
AD-209-1C