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OpenTrials
Completed

NCT Number: NCT00779181

A Dose-Ranging Study of the Safety and Efficacy of ADX415 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Austin, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADX415

Drug

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

Placebo

Drug

Placebo taken three times a day

Primary outcomes

  1. Change in ABPM measures

    Time frame: Baseline to Day 26

Secondary outcomes

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

    Time frame: Throughout treatment period

Sponsors and collaborators

Lead sponsor

Addrenex Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 24, 2008
Registry last updated
Dec 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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