Determining the Optimal Dose of AD-209 in Patients With Essential Hypertension

Addpharma

Status and phase: Completed; Phase 2

Conditions: Hypertension,Essential

Treatments: Drug: Amlodipine high; Drug: AD209; Drug: Telmisartan; Drug: Amlodipine low

Study type: Interventional

Funder types: Industry

Identifiers

NCT04218552

AD-209P2

Details and patient eligibility

About

The purpose of this study is to determine the optimal dose of AD-209 in patients with Essential Hypertension.

Full description

Condition or disease : hypertension Intervention/treatment Drug : AD-209-H Drug : AD-209-M Drug : AD-209-L Drug : Placebo Drug : Amlodipine Drug : Telmisartan Phase : Phase 2

Enrollment: 176 patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Other inclusions applied

Exclusion criteria

• orthostatic hypotension with symptom
• Other exclusions applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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176 participants in 7 patient groups, including a placebo group

Experimental 1

Experimental group

Description:

AD-209 High

Treatment:

Drug: AD209

Experimental 2

Experimental group

Description:

AD-209 Middle

Treatment:

Drug: AD209

Experimental 3

Experimental group

Description:

AD-209 Low

Treatment:

Drug: AD209

Active Comparator 1

Active Comparator group

Description:

Amlodipine Low

Treatment:

Drug: Amlodipine low

Active Comparator 2

Active Comparator group

Description:

Amlodipine High

Treatment:

Drug: Amlodipine high

Active Comparator 3

Active Comparator group

Description:

Telmisartan

Treatment:

Drug: Telmisartan

Placebo comparator

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Amlodipine low

Drug: Telmisartan

Drug: AD209

Drug: Amlodipine high