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

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: ADX415; Drug: Placebo

• Registration Number: NCT00779181
• Lead Sponsor: Addrenex Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Status Verified: 2008-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2008-12-16
• Last Update Posted: 2008-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADX415 (high dose)	ADX415	A high dose of ADX415
ADX415 (mid level dose)	ADX415	A mid level dose of ADX415
Placebo	Placebo	-
ADX415 (low dose)	ADX415	A low dose of ADX415

Primary Outcome Measures

Name	Time	Method
Change in ABPM measures	Baseline to Day 26

Secondary Outcome Measures

Name	Time	Method
Treatment emergent adverse events, lab tests, vitals signs, and ECGs	Throughout treatment period