Clinical trial

A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AD-227A and AD-227B Combination Treatment in Patients With Essential Hypertension

ID

Name

AD-227P3

Description

The purpose of this study is to evaluate the efficacy and safety of co-administration of AD-227A and AD-227B in patients with essential hypertension

Trial arms

Trial start

2024-06-17

Estimated PCD

2025-01-31

Trial end

2025-01-31

Status

Not yet recruiting

Phase

Early phase I

Treatment

AD-227A

Per Oral, 1 Tablet, Once a day for 8 weeks

Arms:

AD-227A, Co-administration of AD-227A and AD-227B, Co-administration of AD-227A and AD-227C

AD-227B

Per Oral, 1 Tablet, Once a day for 8 weeks

Arms:

Co-administration of AD-227A and AD-227B

AD-227C

Per Oral, 1 Tablet, Once a day for 8 weeks

Arms:

Co-administration of AD-227A and AD-227C

Placebo of AD-227B

Per Oral, 1 Tablet, Once a day for 8 weeks

Arms:

AD-227A, Co-administration of AD-227A and AD-227C

Placebo of AD-227C

Per Oral, 1 Tablet, Once a day for 8 weeks

Arms:

AD-227A, Co-administration of AD-227A and AD-227B

Size

251

Primary endpoint

Change in MSSBP

Baseline to Week8

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': 251, 'type': 'ESTIMATED'}}

Updated at

2024-06-05

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product