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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00847899
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : November 20, 2009
Information provided by:
Arete Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Impaired Glucose Tolerance Drug: AR9281 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Drug: AR9281
AR9281 taken in BID dosing regimen for 28 days

Active Comparator: 2
Drug: AR9281
AR9281 taken in TID dosing regimen for 28 days

Placebo Comparator: 3
Drug: Placebo
Placebo taken in BID dosing regimen for 28 days

Placebo Comparator: 4
Drug: Placebo
Placebo taken in TID dosing regimen for 28 days

Primary Outcome Measures :
  1. Systolic and Diastolic blood pressure [ Time Frame: 28 day treatment period ]
  2. Glucose dynamics and insulin sensitivity [ Time Frame: 28 day treatment period ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00847899

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United States, Alabama
Arete Investigational site
Mobile, Alabama, United States, 36617
Arete Investigational site
Muscle Shoals, Alabama, United States, 35662
United States, California
Arete Investigational site
Anaheim, California, United States, 92801
Arete Investigational site
Concord, California, United States, 94520
Arete Investigational site
Mission Hills, California, United States, 91345
United States, Florida
Arete Investigational site
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
United States, Georgia
Arete Investigational site
Marietta, Georgia, United States, 30066
United States, Illinois
Arete Investigational site
Addison, Illinois, United States, 60101
United States, Kentucky
Arete Investigational site
Louisville, Kentucky, United States, 40213
United States, Massachusetts
Arete Investigational site
Brockton, Massachusetts, United States, 02301
United States, Michigan
Arete Investigational site
Paw Paw, Michigan, United States, 49079
United States, Nevada
Arete Investigational site
Las Vegas, Nevada, United States, 89123
United States, Ohio
Arete Investigational site
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
United States, Oklahoma
Arete Investigational site
Oklahoma City, Oklahoma, United States, 73132
United States, Oregon
Arete Investigational site
Eugene, Oregon, United States, 97404
United States, Texas
Arete Investigational site
Austin, Texas, United States, 78704
Arete Investigational site
Dallas, Texas, United States, 75251
Arete Investigational site
San Antonio, Texas, United States, 78229
United States, Utah
Arete Investigational site
Orem, Utah, United States, 84058
Sponsors and Collaborators
Arete Therapeutics
Additional Information:
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Responsible Party: Calvert Lee, Sr. CRA, Arete Therapeutics Identifier: NCT00847899    
Other Study ID Numbers: AR9281-CLN-003
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: November 20, 2009
Last Verified: November 2009
Keywords provided by Arete Therapeutics:
impaired glucose tolerance
s-EH enzyme inhibition
Additional relevant MeSH terms:
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Glucose Intolerance
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases