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NCT00847899 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00847899
Other study ID # AR9281-CLN-003
Secondary ID
Status Completed
Phase Phase 2
First received February 17, 2009
Last updated November 18, 2009
Start date January 2009
Est. completion date November 2009

Study information
Verified date November 2009
Source Arete Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date November 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AR9281
AR9281 taken in BID dosing regimen for 28 days
• AR9281
AR9281 taken in TID dosing regimen for 28 days
• Placebo
Placebo taken in BID dosing regimen for 28 days
• Placebo
Placebo taken in TID dosing regimen for 28 days

Locations
Country Name City State
United States Arete Investigational site Addison Illinois
United States Arete Investigational site Anaheim California
United States Arete Investigational site Austin Texas
United States Arete Investigational site Bradenton Florida
United States Arete Investigational site Brockton Massachusetts
United States Arete Investigational site Cincinnati Ohio
United States Arete Investigational site Cincinnati Ohio
United States Arete Investigational site Concord California
United States Arete Investigational site Dallas Texas
United States Arete Investigational site Deland Florida
United States Arete Investigational site Eugene Oregon
United States Arete Investigational site Jacksonville Florida
United States Arete Investigational site Largo Florida
United States Arete Investigational site Las Vegas Nevada
United States Arete Investigational site Louisville Kentucky
United States Arete Investigational site Marietta Georgia
United States Arete Investigational site Marion Ohio
United States Arete Investigational site Miami Florida
United States Arete Investigational site Mission Hills California
United States Arete Investigational site Mobile Alabama
United States Arete investigational site Mt. Gilead Ohio
United States Arete Investigational site Muscle Shoals Alabama
United States Arete Investigational site New Port Richey Florida
United States Arete Investigational site Oklahoma City Oklahoma
United States Arete Investigational site Orem Utah
United States Arete Investigational site Paw Paw Michigan
United States Arete Investigational site Pembroke Pines Florida
United States Arete Investigational site Port Orange Florida
United States Arete Investigational site San Antonio Texas
United States Arete Investigational site Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Arete Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Systolic and Diastolic blood pressure 28 day treatment period No
Primary Glucose dynamics and insulin sensitivity 28 day treatment period No
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