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

NCT ID: NCT00847899

Last Updated: 2009-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Impaired Glucose Tolerance

Keywords

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hypertension impaired glucose tolerance s-EH enzyme inhibition pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

AR9281

Group Type ACTIVE_COMPARATOR

AR9281

Intervention Type DRUG

AR9281 taken in BID dosing regimen for 28 days

2

AR9281

Group Type ACTIVE_COMPARATOR

AR9281

Intervention Type DRUG

AR9281 taken in TID dosing regimen for 28 days

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo taken in BID dosing regimen for 28 days

4

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo taken in TID dosing regimen for 28 days

Interventions

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AR9281

AR9281 taken in BID dosing regimen for 28 days

Intervention Type DRUG

AR9281

AR9281 taken in TID dosing regimen for 28 days

Intervention Type DRUG

Placebo

Placebo taken in BID dosing regimen for 28 days

Intervention Type DRUG

Placebo

Placebo taken in TID dosing regimen for 28 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arete Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Arete Therapeutics

Locations

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Arete Investigational site

Mobile, Alabama, United States

Site Status

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Muscle Shoals, Alabama, United States

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Anaheim, California, United States

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Concord, California, United States

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Mission Hills, California, United States

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Bradenton, Florida, United States

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DeLand, Florida, United States

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Jacksonville, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Pembroke Pines, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Marietta, Georgia, United States

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Addison, Illinois, United States

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Louisville, Kentucky, United States

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Brockton, Massachusetts, United States

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Paw Paw, Michigan, United States

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Las Vegas, Nevada, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Marion, Ohio, United States

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Mount Gilead, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Orem, Utah, United States

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Countries

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United States

Related Links

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http://www.aretetherapeutics.com

Arete Therapeutics home website

Other Identifiers

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AR9281-CLN-003

Identifier Type: -

Identifier Source: org_study_id