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CompletedNCT00779181Updated Dec 17, 2008

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

A Phase 2 interventional study of ADX415 and ADX415 in Hypertension, sponsored by Addrenex Pharmaceuticals, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-12-17.

Sponsored by Addrenex Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypertension

Keywords

  • Hypertension
  • High blood pressure
  • Htn
  • Addrenex
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 80 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Addrenex Pharmaceuticals, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    ADX415 (high dose)

    A high dose of ADX415

    Drug: ADX415

  • Experimental
    ADX415 (mid level dose)

    A mid level dose of ADX415

    Drug: ADX415

  • Experimental
    ADX415 (low dose)

    A low dose of ADX415

    Drug: ADX415

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugADX415

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

  • DrugADX415

    ADX415 taken three times a day to achieve a mid level total daily dose

  • DrugADX415

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

  • DrugPlacebo

    Placebo taken three times a day

06

What researchers measure

Primary outcomes

  1. Change in ABPM measures

    Time frame: Baseline to Day 26

Secondary outcomes

  1. Treatment emergent adverse events, lab tests, vitals signs, and ECGs

    Time frame: Throughout treatment period

07

Study locations

3 sites
  • Austin, Texas 78704, United States
  • Austin, Texas 78759, United States
  • San Antonio, Texas 78217, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00779181
Lead sponsor
Addrenex Pharmaceuticals, Inc.
First posted
Oct 24, 2008
Start date
Oct 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Dec 17, 2008

Study contacts

Moise Khayrallah, PhD
study director · Addrenex Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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