Clinical trial NCT00847899: Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Impaired Glucose Tolerance
Keywords: hypertension
impaired glucose tolerance
s-EH enzyme inhibition
pre-diabetes
Lead sponsor: Arete Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Systolic and Diastolic blood pressure
timeFrame: 28 day treatment period
measure: Glucose dynamics and insulin sensitivity
timeFrame: 28 day treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Arete Investigational site
state: Alabama
city: Muscle Shoals
country: United States
facility: Arete Investigational site
state: Alabama
city: Anaheim
country: United States
facility: Arete Investigational site
state: California
city: Concord
country: United States
facility: Arete Investigational site
state: California
city: Mission Hills
country: United States
facility: Arete Investigational site
state: California
city: Bradenton
country: United States
facility: Arete Investigational site
state: Florida
city: Deland
country: United States
facility: Arete Investigational site
state: Florida
city: Jacksonville
country: United States
facility: Arete Investigational site
state: Florida
city: Largo
country: United States
facility: Arete Investigational site
state: Florida
city: Miami
country: United States
facility: Arete Investigational site
state: Florida
city: New Port Richey
country: United States
facility: Arete Investigational site
state: Florida
city: Pembroke Pines
country: United States
facility: Arete Investigational site
state: Florida
city: Port Orange
country: United States
facility: Arete Investigational site
state: Florida
city: Tampa
country: United States
facility: Arete Investigational site
state: Florida
city: Marietta
country: United States
facility: Arete Investigational site
state: Georgia
city: Addison
country: United States
facility: Arete Investigational site
state: Illinois
city: Louisville
country: United States
facility: Arete Investigational site
state: Kentucky
city: Brockton
country: United States
facility: Arete Investigational site
state: Massachusetts
city: Paw Paw
country: United States
facility: Arete Investigational site
state: Michigan
city: Las Vegas
country: United States
facility: Arete Investigational site
state: Nevada
city: Cincinnati
country: United States
facility: Arete Investigational site
state: Ohio
city: Cincinnati
country: United States
facility: Arete Investigational site
state: Ohio
city: Marion
country: United States
facility: Arete Investigational site
state: Ohio
city: Mt. Gilead
country: United States
facility: Arete investigational site
state: Ohio
city: Oklahoma City
country: United States
facility: Arete Investigational site
state: Oklahoma
city: Eugene
country: United States
facility: Arete Investigational site
state: Oregon
city: Austin
country: United States
facility: Arete Investigational site
state: Texas
city: Dallas
country: United States
facility: Arete Investigational site
state: Texas
city: San Antonio
country: United States
facility: Arete Investigational site
state: Texas
city: Orem
country: United States
facility: Arete Investigational site
state: Utah
Study officials:
References: