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

December 16, 2008 updated by: Addrenex Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78759
      • Austin, Texas, United States, 78704
      • San Antonio, Texas, United States, 78217

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo taken three times a day
Experimental: ADX415 (high dose)
A high dose of ADX415
Drug: ADX415
ADX415 taken three times a day to achieve a high total daily dose
Drug: ADX415
ADX415 taken three times a day to achieve a mid level total daily dose
Drug: ADX415
ADX415 taken three times a day to achieve a low total daily dose
Experimental: ADX415 (mid level dose)
A mid level dose of ADX415
Drug: ADX415
ADX415 taken three times a day to achieve a high total daily dose
Drug: ADX415
ADX415 taken three times a day to achieve a mid level total daily dose
Drug: ADX415
ADX415 taken three times a day to achieve a low total daily dose
Experimental: ADX415 (low dose)
A low dose of ADX415
Drug: ADX415
ADX415 taken three times a day to achieve a high total daily dose
Drug: ADX415
ADX415 taken three times a day to achieve a mid level total daily dose
Drug: ADX415
ADX415 taken three times a day to achieve a low total daily dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in ABPM measures
Time Frame: Baseline to Day 26
Baseline to Day 26

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addrenex Pharmaceuticals, Inc.

Investigators

  • Study Director: Moise Khayrallah, PhD, Addrenex Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 23, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (Estimate)

October 24, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2008

Last Update Submitted That Met QC Criteria

December 16, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX415-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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