A Dose-Ranging Study of the Safety and Efficacy of ADX415 in the Treatment of Essential Hypertension

A Phase 2, Dose-Ranging Study of the Safety and Efficacy of ADX415 Immediate-Release in the Treatment of Essential Hypertension

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00779181

Enrollment

Registered

2008-10-24

Start date

2008-10-31

Completion date

2008-12-31

Last updated

2008-12-17

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

Conditions

Hypertension

Keywords

Hypertension, High blood pressure, Htn, Addrenex

Brief summary

The purpose of this study is to determine a safe and effective dose of ADX415 for the treatment of hypertension.

Interventions

DRUGADX415

ADX415 taken three times a day to achieve a high total daily dose

DRUGPlacebo

Placebo taken three times a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Mild to moderate hypertension * Age 18-75 years, inclusive

Exclusion criteria

* Clinically significant illnesses or abnormalities upon evaluation * Current treatment with 3 or more antihypertensive meds * Presence of Type I or uncontrolled Type II diabetes * Presence of alcohol or drug abuse

Design outcomes

Primary

Measure	Time frame
Change in ABPM measures	Baseline to Day 26

Secondary

Measure	Time frame
Treatment emergent adverse events, lab tests, vitals signs, and ECGs	Throughout treatment period

Countries

United States

Outcome results

None listed

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