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

This study has been completed.
Sponsor:
Information provided by:
Arete Therapeutics
ClinicalTrials.gov Identifier:
NCT00847899
First received: February 17, 2009
Last updated: November 18, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Hypertension
Impaired Glucose Tolerance
Drug: AR9281
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Arete Therapeutics:

Primary Outcome Measures:
  • Systolic and Diastolic blood pressure [ Time Frame: 28 day treatment period ] [ Designated as safety issue: No ]
  • Glucose dynamics and insulin sensitivity [ Time Frame: 28 day treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847899

  Show 30 Study Locations
Sponsors and Collaborators
Arete Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Calvert Lee, Sr. CRA, Arete Therapeutics
ClinicalTrials.gov Identifier: NCT00847899     History of Changes
Other Study ID Numbers: AR9281-CLN-003
Study First Received: February 17, 2009
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Arete Therapeutics:
hypertension
impaired glucose tolerance
s-EH enzyme inhibition
pre-diabetes

Additional relevant MeSH terms:
Hypertension
Glucose Intolerance
Vascular Diseases
Cardiovascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 23, 2014