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

Phase 2CompletedNCT00779181

Addrenex Pharmaceuticals, Inc.80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension

Interventions

ADX415DRUG

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

ADX415DRUG

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

ADX415DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Austin, Texas, United States

Unnamed facility

Austin, Texas, United States

Unnamed facility

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Change in ABPM measures

Time frame: Baseline to Day 26

Secondary Outcomes

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

Time frame: Throughout treatment period

Data from ClinicalTrials.gov

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