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

A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Determine the Optimal Dose of AD-209 in Patients With Essential Hypertension

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04218552
Enrollment
176
Registered
2020-01-06
Start date
2020-02-25
Completion date
2021-02-25
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension,Essential

Brief summary

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

Detailed 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

Interventions

DRUGTelmisartan

PO, Once daily(QD), 8weeks

DRUGAD209

PO, Once daily(QD), 8weeks

DRUGAmlodipine low

PO, Once daily(QD), 8weeks

DRUGAmlodipine high

PO, Once daily(QD), 8weeks

Sponsors

Addpharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No

Inclusion criteria

* Signed informed consent * Other inclusions applied

Exclusion criteria

* orthostatic hypotension with symptom * Other exclusions applied

Design outcomes

Primary

MeasureTime frameDescription
1. Change rate of MSSBP[ Time Frame: baseline, 8 weeks ]Change from baseline in mean sitting systolic blood pressure

Secondary

MeasureTime frameDescription
1. Change rate of MSSBP[ Time Frame: baseline, 4 weeks ]Change from baseline in mean sitting systolic blood pressure
2. Change rate of MSDBP[ Time Frame: baseline, 4 weeks, 8 weeks ]Change from baseline in mean sitting diastolic blood pressure
3. Proportion of BP normalization MSSBP/MSDBP < 140/90 mmHg MSSBP/MSDBP < 130/80 mmHg (Diabetes or Chronic renal disease)[ Time Frame: 4 weeks, 8 weeks ]Proportion of subjects achieving blood pressure control
4.Reaction rate of BP[ Time Frame: baseline, 4 weeks, 8 weeks ]Proportion of reduction from baseline in MSSBP/MSDBP ≥ 20/10 mmHg

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026