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

NCT ID: NCT00779181

Last Updated: 2008-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Conditions

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Hypertension

Keywords

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Hypertension High blood pressure Htn Addrenex

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ADX415 (high dose)

A high dose of ADX415

Group Type EXPERIMENTAL

ADX415

Intervention Type DRUG

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

ADX415 (mid level dose)

A mid level dose of ADX415

Group Type EXPERIMENTAL

ADX415

Intervention Type DRUG

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

ADX415 (low dose)

A low dose of ADX415

Group Type EXPERIMENTAL

ADX415

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo taken three times a day

Interventions

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ADX415

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

Intervention Type DRUG

ADX415

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

Intervention Type DRUG

ADX415

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

Intervention Type DRUG

Placebo

Placebo taken three times a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Addrenex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Addrenex Pharmaceuticals, Inc.

Principal Investigators

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Moise Khayrallah, PhD

Role: STUDY_DIRECTOR

Addrenex Pharmaceuticals, Inc.

Locations

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Austin, Texas, United States

Site Status

Austin, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ADX415-301

Identifier Type: -

Identifier Source: org_study_id