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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ADX415
ADX415
ADX415
Placebo
Sponsored by
Addrenex Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, High blood pressure, Htn, Addrenex

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ADX415 (high dose)

ADX415 (mid level dose)

ADX415 (low dose)

Placebo

Arm Description

A high dose of ADX415

A mid level dose of ADX415

A low dose of ADX415

Outcomes

Primary Outcome Measures

Change in ABPM measures

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2008
Last Updated
December 16, 2008
Sponsor
Addrenex Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00779181
Brief Title
A Dose-Ranging Study of the Safety and Efficacy of ADX415 in the Treatment of Essential Hypertension
Official Title
A Phase 2, Dose-Ranging Study of the Safety and Efficacy of ADX415 Immediate-Release in the Treatment of Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Addrenex Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, High blood pressure, Htn, Addrenex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADX415 (high dose)
Arm Type
Experimental
Arm Description
A high dose of ADX415
Arm Title
ADX415 (mid level dose)
Arm Type
Experimental
Arm Description
A mid level dose of ADX415
Arm Title
ADX415 (low dose)
Arm Type
Experimental
Arm Description
A low dose of ADX415
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ADX415
Intervention Description
ADX415 taken three times a day to achieve a high total daily dose
Intervention Type
Drug
Intervention Name(s)
ADX415
Intervention Description
ADX415 taken three times a day to achieve a mid level total daily dose
Intervention Type
Drug
Intervention Name(s)
ADX415
Intervention Description
ADX415 taken three times a day to achieve a low total daily dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taken three times a day
Primary Outcome Measure Information:
Title
Change in ABPM measures
Time Frame
Baseline to Day 26
Secondary Outcome Measure Information:
Title
Treatment emergent adverse events, lab tests, vitals signs, and ECGs
Time Frame
Throughout treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moise Khayrallah, PhD
Organizational Affiliation
Addrenex Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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