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

November 18, 2009 updated by: Arete Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • Arete Investigational site
      • Muscle Shoals, Alabama, United States, 35662
        • Arete Investigational site
    • California
      • Anaheim, California, United States, 92801
        • Arete Investigational site
      • Concord, California, United States, 94520
        • Arete Investigational site
      • Mission Hills, California, United States, 91345
        • Arete Investigational site
    • Florida
      • Bradenton, Florida, United States, 34203
        • Arete Investigational site
      • Deland, Florida, United States, 32720
        • Arete Investigational site
      • Jacksonville, Florida, United States, 32216
        • Arete Investigational site
      • Largo, Florida, United States, 33770
        • Arete Investigational site
      • Miami, Florida, United States, 33169
        • Arete Investigational site
      • New Port Richey, Florida, United States, 34652
        • Arete Investigational site
      • Pembroke Pines, Florida, United States, 33026
        • Arete Investigational site
      • Port Orange, Florida, United States, 32127
        • Arete Investigational site
      • Tampa, Florida, United States, 33606
        • Arete Investigational site
    • Georgia
      • Marietta, Georgia, United States, 30066
        • Arete Investigational site
    • Illinois
      • Addison, Illinois, United States, 60101
        • Arete Investigational site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Arete Investigational site
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Arete Investigational site
    • Michigan
      • Paw Paw, Michigan, United States, 49079
        • Arete Investigational site
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Arete Investigational site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Arete Investigational site
      • Cincinnati, Ohio, United States, 45245
        • Arete Investigational site
      • Marion, Ohio, United States, 43302
        • Arete Investigational site
      • Mt. Gilead, Ohio, United States, 43338
        • Arete Investigational site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73132
        • Arete Investigational site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Arete Investigational site
    • Texas
      • Austin, Texas, United States, 78704
        • Arete Investigational site
      • Dallas, Texas, United States, 75251
        • Arete Investigational site
      • San Antonio, Texas, United States, 78229
        • Arete Investigational site
    • Utah
      • Orem, Utah, United States, 84058
        • Arete Investigational site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
Placebo
Drug: Placebo
Placebo taken in BID dosing regimen for 28 days
Drug: Placebo
Placebo taken in TID dosing regimen for 28 days
Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo taken in BID dosing regimen for 28 days
Drug: Placebo
Placebo taken in TID dosing regimen for 28 days
Active Comparator: 1
AR9281
Drug: AR9281
AR9281 taken in BID dosing regimen for 28 days
Drug: AR9281
AR9281 taken in TID dosing regimen for 28 days
Active Comparator: 2
AR9281
Drug: AR9281
AR9281 taken in BID dosing regimen for 28 days
Drug: AR9281
AR9281 taken in TID dosing regimen for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systolic and Diastolic blood pressure
Time Frame: 28 day treatment period
28 day treatment period
Glucose dynamics and insulin sensitivity
Time Frame: 28 day treatment period
28 day treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arete Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

November 20, 2009

Last Update Submitted That Met QC Criteria

November 18, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR9281-CLN-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe