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

Sponsor

Arete Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00847899

Collaborator

(none)

150

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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: AR9281 Drug: Placebo Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2009

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Systolic and Diastolic blood pressure [28 day treatment period]
Glucose dynamics and insulin sensitivity [28 day treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Arete Investigational site	Mobile	Alabama	United States	36617
2	Arete Investigational site	Muscle Shoals	Alabama	United States	35662
3	Arete Investigational site	Anaheim	California	United States	92801
4	Arete Investigational site	Concord	California	United States	94520
5	Arete Investigational site	Mission Hills	California	United States	91345
6	Arete Investigational site	Bradenton	Florida	United States	34203
7	Arete Investigational site	Deland	Florida	United States	32720
8	Arete Investigational site	Jacksonville	Florida	United States	32216
9	Arete Investigational site	Largo	Florida	United States	33770
10	Arete Investigational site	Miami	Florida	United States	33169
11	Arete Investigational site	New Port Richey	Florida	United States	34652
12	Arete Investigational site	Pembroke Pines	Florida	United States	33026
13	Arete Investigational site	Port Orange	Florida	United States	32127
14	Arete Investigational site	Tampa	Florida	United States	33606
15	Arete Investigational site	Marietta	Georgia	United States	30066
16	Arete Investigational site	Addison	Illinois	United States	60101
17	Arete Investigational site	Louisville	Kentucky	United States	40213
18	Arete Investigational site	Brockton	Massachusetts	United States	02301
19	Arete Investigational site	Paw Paw	Michigan	United States	49079
20	Arete Investigational site	Las Vegas	Nevada	United States	89123
21	Arete Investigational site	Cincinnati	Ohio	United States	45219
22	Arete Investigational site	Cincinnati	Ohio	United States	45245
23	Arete Investigational site	Marion	Ohio	United States	43302
24	Arete investigational site	Mt. Gilead	Ohio	United States	43338
25	Arete Investigational site	Oklahoma City	Oklahoma	United States	73132
26	Arete Investigational site	Eugene	Oregon	United States	97404
27	Arete Investigational site	Austin	Texas	United States	78704
28	Arete Investigational site	Dallas	Texas	United States	75251
29	Arete Investigational site	San Antonio	Texas	United States	78229
30	Arete Investigational site	Orem	Utah	United States	84058