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

Phase 2

Completed

• Conditions: Hypertension; Impaired Glucose Tolerance
• Interventions: Drug: AR9281; Drug: Placebo

• Registration Number: NCT00847899
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-19
• Primary Completion: 2009-10
• Status Verified: 2009-11
• Study Completion: 2009-11
• Last Update Submitted: 2009-11-18
• Last Update Posted: 2009-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AR9281	AR9281
2	AR9281	AR9281
3	Placebo	Placebo
4	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Systolic and Diastolic blood pressure	28 day treatment period
Glucose dynamics and insulin sensitivity	28 day treatment period

Trial Locations

Locations (2)

Arete Investigational site; 🇺🇸 Orem, Utah, United States

Arete investigational site; 🇺🇸 Mt. Gilead, Ohio, United States