Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate hypertension.

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Key information

Conditions

Hypertension Cardiovascular Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Impaired Glucose Tolerance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arete Investigational site, Mobile, Alabama, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

mild to moderate hypertension
naive to antihypertensive medication or on two or less antihypertensive medications
impaired glucose tolerance
mild obesity

Exclusion criteria

Diagnosis of Type 1 or Type 2 diabetes
History of severe heart failure
AST, ALT levels more than twice the normal range

Treatment and study plan

AR9281

Drug

AR9281 taken in BID dosing regimen for 28 days

Placebo

Drug

Placebo taken in BID dosing regimen for 28 days

Primary outcomes

Systolic and Diastolic blood pressure

Time frame: 28 day treatment period
Glucose dynamics and insulin sensitivity

Time frame: 28 day treatment period

Sponsors and collaborators

Lead sponsor

Arete Therapeutics

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Exploratory, 28-Day Study to Examine the Effects of AR9281 on Blood Pressure and Glucose Tolerance in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Feb 19, 2009
Registry last updated: Nov 20, 2009

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.

Published trials that share one or more normalized conditions with this study.

Completed