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

Arete Therapeutics

Status and phase: Completed; Phase 2

Conditions: Impaired Glucose Tolerance; Hypertension

Treatments: Drug: AR9281; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00847899

AR9281-CLN-003

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

AR9281

Treatment:

Drug: AR9281

Drug: AR9281

2

Active Comparator group

Description:

AR9281

Treatment:

Drug: AR9281

Drug: AR9281

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo