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

This study has been completed.
Information provided by:
Arete Therapeutics Identifier:
First received: February 17, 2009
Last updated: November 18, 2009
Last verified: November 2009
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 Intervention Phase
Impaired Glucose Tolerance
Drug: AR9281
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Further study details as provided by Arete Therapeutics:

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

Estimated Enrollment: 150
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00847899

  Show 30 Study Locations
Sponsors and Collaborators
Arete Therapeutics
  More Information

Additional Information:
Responsible Party: Calvert Lee, Sr. CRA, Arete Therapeutics Identifier: NCT00847899     History of Changes
Other Study ID Numbers: AR9281-CLN-003
Study First Received: February 17, 2009
Last Updated: November 18, 2009

Keywords provided by Arete Therapeutics:
impaired glucose tolerance
s-EH enzyme inhibition

Additional relevant MeSH terms:
Glucose Intolerance
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases processed this record on May 24, 2017